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Instinct Java Spinal Fixation System Guide

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0% found this document useful (0 votes)
14 views52 pages

Instinct Java Spinal Fixation System Guide

Uploaded by

bhanu8005
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Instinct Java ® ®

Spinal Fixation System

Surgical Technique

Solutions by the people of Zimmer Spine.


[Link]
Instinct Java.
A distinctive spinal fixation platform.

Zimmer Spine's Instinct Java System is a pedicle screw system designed to


provide you with a versatile solution to treat multiple pathologies in a proven
design. The screw fixation utilizes a combination of asymmetrical and dual
threads designed to improve cortical and cancellous bone fixation and to
improve resistance to screw pull-out. The raised dimples and recesses of the
screw heads lock the screws securely to the instrumentation and provide
numerous options for reduction. In addition, the optimized blocker is designed
to limit cross-threading and head splay. The sound design of the Instinct Java
System provides you with the tools you need to treat your patients effectively.
Table of Contents
Introduction 1

Indications/Contraindications 3

Implants 5

Instruments 7

Surgical Technique 13

Instrument Disassembly and Cleaning 35

Kit Contents 37

Warnings and Precautions 45


The Instinct Java System was designed to treat a wide variety of spinal pathologies with intuitive
solutions. We focused our design activities to deliver a simple, easy-to-use system that offers
versatile options to surgeons.

Zimmer Spine is committed to developing a system that offers low profile implants with high
biomechanical strength. The Instinct Java System is based on optimized technologies that minimize
the overall implant volume without compromising performance.

Comprehensive Proven
Surgical technique Technology

Instinct
System

Versatile Simple
Solutions To use

1
• Reduced head diameter offers more room for graft with a lower construct profile.

• Round shape preserves adjacent facets.

• Four recesses enable a powerful connection with the Persuader.

• Raised dimples facilitate a better connection to the Rod Fork.

• Optimized threads are designed to prevent head splay and cross threading.

• Cortical and cancellous advanced threads are designed to maximize pull-out resistance.

• Self-tapping tip saves surgical time.

• Torx interface on blocker is designed to improve resistance to stripping.

2
Indications/Contraindications

Description
The Instinct Java Spinal Fixation System is installed in order to stabilize one or more vertebral
segments from the thoracic spine to the sacrum during the development of bone tissue, using a
top loading technique.

The Instinct Java Fixation System is comprised of various screws, hooks, autostable hooks, offset,
axial and side-by-side connectors and rods, and was designed to temporarily stabilize spinal
segments by means of an osteosynthesis. This system is supplied only in non-sterile form.

For implanting the system, please refer to the brochures on the device, entitled "Instinct Java:
SURGICAL TECHNIQUE" and "Instinct Java: HOOKS SURGICAL TECHNIQUE".

Authorized combinations of medical devices:

The Instinct Java Spinal Fixation System should be used in combination with the dedicated
instruments, container base, tray and case lid, in accordance with the information found in the
associated brochure “Instinct Java: SURGICAL TECHNIQUE”.

The following devices may be used in combination with it:

–– Java TL Transverse Connectors, Ref. Nos. SN2023-0-52055 / SN2023-0-62055 /


®

SN2023‑0-72055 / SN2023-0-82055*
–– Sequoia Adjustable Speedlink II™ Connectors Ref. Nos. 3308-35 / 3309-40 / 3310-50
®

The following devices may also be used in combination with the Instinct Java System, EXCLUDING
the CoCr rods.

–– Universal Clamp™ 5.5mm Ti Implants


–– Nex-Link Band and Inline Rod Connector - 4.0mm x 5.5mm, Ref. Nos. 725-4055 /
®

726‑4055

The Instinct Java axial and side-by-side connectors may be used in combination with Nex-Link 4.0mm
Ti rods Ref. Nos. 724-120 / 724-240 / 724-360 and Optima™ rods Ø 6.0mm Ref. Nos. SG16XX.

Note: Instinct Java Pedicle Screws may be used with Zimmer DTO 5.5 System, according to the
® ®

instructions for use and the surgical technique of Zimmer DTO 5.5 System. This configuration is
only available outside the US. Zimmer DTO 5.5 Implant is not cleared for the US market.

Indications
The Instinct Java Spinal Fixation System is designed for spinal fixation procedures in skeletally
mature patients performed through a posterior approach.

The Instinct Java Spinal Fixation System is indicated for the temporary realignment and
stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until
bony fusion is obtained.

The Instinct Java Spinal Fixation System is indicated to achieve bony fusion via osteosynthesis
at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative
disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history
and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal
deformities, scoliosis, tumor and pseudoarthrosis, or for revision of a failed previous fusion.
*Note: The Java Spinal Fixation System is not cleared for the US market.

3
Contraindications
a. A disorder affecting the normal process of bone remodelling, including but not limited
to severe osteoporosis involving the spine, excessive bone reabsorption, osteopenia, a
primary or metastatic tumor involving the spine, an active infection at the planned point of
intervention or certain metabolic disorders of osteogenesis.

b. Insufficient bone quantity or quality that might compromise rigid fixation of the device.

c. A history of infection.

d. Excessive local inflammation.

e. An open wound.

f. A neuromuscular disorder causing an abnormally high load on the device during the fusion
period.

g. Obesity contributes to a spinal overload that may be excessive enough to cause failure in the
fixation of the device or failure of the device itself.

h. Inadequate tissue covering of the surgical field.

i. Pregnancy.

j. A condition of senility, mental illness or drug addiction. Due to these conditions, the patient
may be particularly unlikely to obey certain limits and recommendations indicated for the
post-operative period, which might lead to failure or other complications.

k. Hypersensitivity or allergy to one or more of the fusion components. If hypersensitivity or


allergy to one or more of the materials is suspected, suitable tests must be done prior to the
selection or implantation of the device.

l. The presence of another medical or surgical condition that may hinder the potential
benefits of the spinal implant surgery, such as the presence of a tumor, a congenital defect,
leukocytosis or a pronounced left shift in the ratio of immature to mature neutrophils.

m. Iliac screws and offset connectors should not be used in cases of tumor or trauma of the
sacrum, when additional screw fixation in S1 is not possible.

4
Instinct Java Implants

Polyaxial Screw Monoaxial Screw


046W0AN2XXXX 046W0AN3XXXX

Polyaxial Reduction Screw Monoaxial Reduction Screw


046W0ANXXXX 046W0AN6XXXX

Polyaxial Iliac Screw


046W0AN2XXXX

Open Offset Lateral Connector Closed Offset Lateral Connector


(15, 25, 50mm; left- or right-angulated 50mm) (15, 25, 50mm; left- or right- angulated 50mm)
046W0AN75XXX 046W0AN76XXX

5
Pre-Contoured Rod (Ti-Alloy) CoCr Rod
(30–120mm) (200, 300, 400, 500mm)
046W0AN51XXX 046W0AN5XXXX

Straight Rod (Ti Alloy)


(30–500mm)
046W0AN50XXX

Blocker SpeedLink II Transverse Connector System


046W0AN00002 3308-35 Small
3309-40 Medium
3310-50 Large

6
Instinct Java Instruments

Square Awl Pedicular Probe


046W1AN00500 046W1AN00530
Pierces the bone cortex at the pedicle entry point. Creates a path through the pedicle and into the
vertebral body.

Pedicular Sounder Straight Flexible Taps


046W1AN00520 Ø4.5–8.5mm
Aids in verifying the integrity of the pedicle and vertebral 046W1AN007XX - 046W1AN008XX
body walls. Tap the pedicle to prepare for screw placement.

Polyaxial 3.5mm Screwdriver Monoaxial Screwdriver


046W1AN00550 046W1AN00560
Connects to either Ratchet Handle to drive and adjust the Connects to either Ratchet Handle to drive and adjust the
polyaxial pedicle screws. monoaxial pedicle screws.

7
Polyaxial 3.5 Screwdriver Universal Monoaxial Screwdriver Universal
046W1AN00555 046W1AN00565
Connects to either Rachet Handle to drive and adjust Connects to either Rachet Handle to drive and adjust
polyaxial screws and polyaxial reduction screws. monoaxial screws and monoaxial reduction screws.

Straight Ratchet Handle Ratcheting T-Handle


046W1AN00570 046W1AN00580
Used in conjunction with all polyaxial and monoaxial drivers. Used in conjunction with all polyaxial and monoaxial drivers.

Straight Ratchet II
046W1AN00585

Trial Rod Rod Bender


(100mm, 200mm) 046W1AN00540
046W1AN00505, 046W1AN00506 Contours the rod to match patient anatomy.
Aids in determining the appropriate rod length and
curvature.

8
Blocker Holder Rod Holder
046W1AN00590 046W1AN00620
Used to pick up and insert the blocker into the screw head. Securely holds the rod for placement and positioning in the
May also be used to adjust the screw head alignment prior construct.
to blocker placement.

Rod Pusher Rod Fork


046W1AN00541 046W1AN00542
Pushes the rod into the screw head in cases where small Pushes the rod into the screw head in cases where moderate
rod reduction is necessary. rod reduction is necessary.

Alligator Persuader Handle Alligator Persuader Sleeve


046W1AN00930 046W1AN00931
Used in conjunction with the Alligator Persuader Sleeve Used in conjunction with the Alligator Persuader Handle to
to push the rod onto the screw head in cases where push the rod onto the screw head in cases where substantial
substantial rod reduction is necessary. rod reduction is necessary.

9
Contraction Forceps Distraction Forceps
046W1AN00810 046W1AN00800
Compresses implants axially along the rod. Distracts implants axially along the rod.

Left Rod Bender Derotation Forceps


046W1AN00551 046W1AN00820

Right Rod Bender Used when rod rotation maneuvers are necessary.
046W1AN00554
Bend the rod in situ.

Derotation Forceps Removal Tab Instrument


046W1AN00610* 046W1AN00670
May be used in place of the Derotation Forceps provided in Removes tabs from reduction screw heads.
the instrument set as dictated by surgeon preference.

* Available by special order only

10
Torque-Limiting T-Handle Countertorque Wrench
046W1AN00650 046W1AN00660
Used in conjunction with the Countertorque Wrench and Provides countertorque leverage for final tightening or
the Final Screwdriver Shaft for final tightening of blockers to blocker removal for polyaxial and monoaxial screws.
10 Nm (90 in-lb).

Countertorque Wrench Universal


046W1AN00661
Provides counter torque leverage for final tightening or
blocker removal for all screws.
Design accommodates reduction screw tabs and offset
lateral connectors.

11
Final Screwdriver Shaft SpeedLink Final Driver Shaft
046W1AN00640 046W1AN00300
Used in conjunction with the Torque-Limiting T-Handle for Final tightens the SpeedLink II System 4.0mm diameter hex.
final tightening of blockers. The SpeedLink Final Driver Shaft can be used with Straight
Ratchet Handle (046W1AN00570) and Ratcheting T-Handle
(046W1AN00580). Do not use with Torque-Limiting T-Handle
(046W1AN00650).

12
Surgical Technique

Pedicle Preparation

Step 1

Pedicle Targeting
Precise positioning of the pedicle entry point is
essential. Proper orientation of the pedicle screw is
dependent upon the position of the pilot hole.

The pilot hole should be made where a line through


the middle of the transverse process crosses a vertical
line at the lateral edge of the facet joints.

Step 2

Awl
Using the Square Awl, pierce the bone cortex at the
entry point.

13
Step 3

Probe
Insert the Pedicular Probe through the pilot hole
into the pedicle to create a path to guide the screw
through the pedicle into the vertebral body.

A depth gauge on the Probe indicates the path


length. Determine the sagittal orientation of the screw
and the degree of convergence appropriate for the
patient’s anatomy.

Step 4

Confirm Pedicle Integrity


After removing the Pedicular Probe, verify the integrity
of the pedicle and the vertebral body walls using the
Pedicular Sounder.

When fully inserted, a forceps can be clamped onto


the Pedicular Sounder to determine the path depth for
choosing the screw size.

Step 5

Tapping
Connect the appropriate diameter Tap to the Straight
Ratchet Handle. Insert the Tap into the pedicle and
rotate it clockwise.

After removing the Tap by turning it counterclockwise,


verify the anatomical integrity with the Pedicular
Sounder.

14
Inserting the Pedicle Screw

Step 6

Screwdriver Assembly
Connect the Polyaxial 3.5mm or Monoaxial
Screwdriver to the Straight Ratchet Handle.

For polyaxial screws, place the appropriate polyaxial


screw on the Polyaxial 3.5mm Screwdriver by aligning
the Screwdriver tip to the female hex on the screw
shank. Secure the polyaxial screw by screwing the
Polyaxial 3.5mm Screwdriver sleeve clockwise into
the screw head.

For monoaxial screws, place the appropriate


monoaxial screw on the Monoaxial Screwdriver and
secure it by screwing the sleeve clockwise into the
screw head.

Lock the Polyaxial or Monoaxial Screwdriver sleeve


by turning the collet clockwise. This secure locking
system prevents screw loosening during insertion. Do
not overtighten the collet.

Note: Choose screw size and diameter according to the


patient’s anatomy and surgeon preference. Screw diameters
of 4.5mm and 5.5mm are recommended for use in the
thoracic spine.

Step 7

Screw Insertion
Insert the screw through the pedicle pathway until it
reaches the proper dorsal height.

15
Step 8

Instrument Removal
1 Release the Polyaxial or Monoaxial Screwdriver by
unlocking the collet counterclockwise. The sleeve can
then be turned counterclockwise to loosen the screw
head.

Repeat this procedure for all the screws of the


2 construct.

Rod Preparation & Insertion

Step 9

Rod Bending
Use the rod bender to prepare and contour the rods
by progressive bends until obtaining a shape similar
to that defined by the Trial Rod.

Pre-contoured versions simplify the initial


approximation.

16
Step 10

Rod Insertion
The proximal tip of the Blocker Holder can be used to
adjust the head alignments prior to rod insertion.

Use the Rod Holder to position the rod within the


screw heads.

Step 11

Blockers
Insert the Blocker Holder into the side of the blocker
marked with an etched cross. Align the Blocker Holder
with the screw head and introduce the blocker.

Turn the blocker until it comes into contact with the


rod, but is not tightened. Repeat this procedure for all
the blockers of the construct.

Note: At least 2mm of the rod should be left outside of the


tulip head before tightening the blocker.

17
Rod Reduction Options
For any rod approximation, the Instinct Java System offers three options for rod reduction.

Step 12 Option 1: Slight Reductions

Step 12 Option 1

Rod Pusher
For the smallest reductions, the rod pusher can be
used to directly introduce the rod into the screw head.

Step 12 Option 2: Moderate Reductions

Step 12 Option 2a

Rod Fork
For moderate reductions, the Rod Fork may be used.
Align the prongs of the forceps vertically in the screw
head dimples. Lock the Rod Fork ratchet mechanism
and use the Rod Fork as a lever to introduce the rod
into the screw head.

18
Step 12 Option 2b

Blocker Placement
Insert the blocker with the Blocker Holder.

Step 12 Option 3 : Substantial Reductions

Step 12 Option 3a

Alligator Persuader
For substantial reductions, use the Alligator Persuader
to reduce the rod. Align the four prongs at the distal
end of the shaft with the screw head recesses.

Step 12 Option 3b

Squeeze the handle to bring the prongs into contact


with the screw head to provide stable fixation; slide
the external sleeve onto the shaft to push the rod into
the screw head.

The ratchet offers a controlled reduction maneuver.

To maintain the appropriate reduction, screw the


knob clockwise until it reaches the sleeve.

19
Step 12 Option 3c

Additional Reduction
The handle can be removed by pressing the lateral
button and can be used on the second Persuader
shaft to accomplish bilateral spondy reduction.

Step 12 Option 3d

The handle can be used in the sagittal plane or in the


frontal plane, depending on the surgeon’s preference.

Step 12 Option 3e

When the desired reduction has been achieved, use


the Blocker Holder to advance the blocker through the
Persuader shaft.

Note: The Aligator Persuader should not be used with offset


connectors or reduction screws, prior to tab removal.

20
Step 12 Option 3f

Persuader Removal
To remove the Persuader, unscrew the knob and
release the handle ratchet. Pull the sleeve back fully
to completely disconnect from the screw head.

Step 12 Option 4: Reduction Screws

Step 12 Option 4a-1

Screwdriver Assembly - Reduction Screws


For reduction screws, connect either the Universal
Monoaxial Screwdriver or Universal Polyaxial
Screwdriver to the desired ratchet handle.

Step 12 Option 4a-2

Universal Polyaxial Screwdriver Assembly


For Polyaxial Reduction screws, connect the ratchet
handle to the driver shaft. Place the appropriate
length screw on the Universal Polyaxial Screwdriver by
aligning the Screwdriver tip to the female hex on the
screw shank. Provisionally secure the Polyaxial Screw
by turning the Screwdriver sleeve clockwise. To ensure
that the screw is secure, grasp the sleeve with one
hand and with the ratchet in neutral position, turn the
handle counterclockwise to fully tighten the screw.

The sleeve of the driver is then locked by tightening


the collet clockwise to the black line marked “lock.”

21
Step 12 Option 4a-3

Universal Monoaxial Screwdriver Assembly


For monoaxial reduction screws, connect the ratchet
handle to the driver shaft. Place the appropriate
length screw on the Universal Monoaxial Screwdriver
and provisionally secure the screw by turning the
Screwdriver sleeve clockwise. To ensure that the
screw is secure, grasp the sleeve with one hand and
with the ratchet in neutral position, turn the handle
counterclockwise to fully tighten the screw.

The sleeve of the driver is then locked by tightening


the collet clockwise to the black line marked “lock.”

Step 12 Option 4b

Screw Insertion
Insert the screw through the pedicle pathway until it
reaches the proper dorsal height.

Step 12 Option 4c

Instrument Removal
To release either the Universal Monoaxial or
2 Polyaxial Screwdriver, loosen the collet by turning it
counterclockwise and unthread the screwdriver from
the screw by turning the ratchet handle clockwise with
1
one hand, while holding the screwdriver sleeve in
place with the other.

22
Step 12 Option 4d

Rod Placement
Insert the rod into the reduction tulip head. Place the
Counter-Torque Wrench Universal over the reduction
screw head and ensure that it is securely seated on
the rod.

Note: The Counter-Torque Wrench Universal must be used


during blocker advancement.

Step 12 Option 4e

Reduction
Using the Torque-Limiting Handle and Final Driver,
advance the blocker to reduce the rod. After fully
reducing the rod, final tighten the blocker. An audible
click will indicate that the torque limit has been
reached.

Note: The blocker must be final tightened prior to removal of


the reduction tabs.

Step 12 Option 4f

Tab Removal
Use the Removal Tab Instrument to remove the
Reduction Screw tabs. Bending the tab medial to
lateral will release it from the tulip head.

Repeat for the second tab.

23
Compression and Distraction (If Necessary)

Step 13

Compression and Distraction


To compress, lock one implant using the Final
Screwdriver Shaft and the Torque-Limiting T-Handle.
Place the Contraction Forceps cephalad and caudal
to the screw heads and squeeze the handle until
compression is completed.

To distract, lock one implant using the Final


Screwdriver Shaft and the Torque-Limiting T-Handle.
Place the Distraction Forceps between the screw
heads and squeeze the handle until distraction is
achieved (see illustration).

Rod Manipulation Options

Step 14

In Situ Bending (If Necessary)


Provisionally tighten the implants using the Final
Screwdriver Shaft and the Torque-Limiting T-Handle.
Use the In Situ Benders in the sagittal plane to restore
the lordotic curve.

24
Step 15

Rod Derotation (If Necessary)


Derotation maneuvers can be performed with the
Derotation Forceps.

Final Tightening

Step 16a

Final Tightening
Once all the reduction maneuvers have been
completed, all of the blockers must be locked.

Connect the Final Screwdriver Shaft to the Torque-


Limiting T-Handle.

Pass the Final Screwdriver into the Countertorque


Wrench and insert it into the blocker.

Step 16b

Turn the Screwdriver clockwise until the Torque-


Limiting T-Handle releases.

Note: Always use the Torque-Limiting T-Handle for final


tightening.

Note: As a security, always repeat the tightening step on all


implants after in situ bending steps.

25
Iliac Fixation (if necessary)

Step 17a

Awl
After selecting the entry point, use the Square Awl to
pierce the bone cortex and create a pilot hole.

Step 17b

Probe
Determine the optimal trajectory of the pathway for
the patient’s anatomy. Insert the Probe through the
pilot hole into the ilium to create a path to guide the
screw.

Step 17c

Confirm Pathway Integrity


After removing the probe, verify the integrity of
the cortical walls by using the Sounder. When fully
inserted, forceps can be clamped onto the Sounder to
mark the path depth and assist in screw selection.

26
Step 17d

Tapping
Connect the appropriate diameter Tap to the Ratchet
Handle. Insert the Tap into the Ilium and advance the
threads by rotating the handle clockwise.

After removing the tap by rotating counterclockwise,


the integrity of the cortical walls may again be verified
by using the Sounder.

Step 17e

Polyaxial Screwdriver Assembly


Assemble the Polyaxial Screwdriver and screw per the
instructions in Step 12 Option 4.

Step 17f

Screw Insertion
Insert the screw into the pilot hole and advance it to
the desired dorsal height by turning the Screwdriver
clockwise.

27
Step 17g

Instrument Removal
To release the screwdriver, loosen the collet by turning
2 it counterclockwise and unthread the screwdriver from
the screw by turning the ratchet handle clockwise with
one hand and holding the driver sleeve in place with
1
the other.

Step 17h

Offset Connector Placement


Lateral connectors are utilized to facilitate rod
placement and bridge the construct.

Determine the appropriate length lateral connector.


Place the lateral connector in the tulip head of the iliac
screw in a preferred orientation.

Step 17i

Blocker Placement – Iliac Screws


While holding the lateral connector in place,
provisionally tighten the blocker in the tulip head of
the iliac screw with the Blocker Holder.

Note: At least 2mm of the offset rod should be left outside


the tulip head before tightening the blocker.

28
Step 17j

Rod Insertion
Select the appropriate length rod and cut to a desired
length. Rods may be bent to facilitate placement.
Place the rod in the lateral connector, followed by
each remaining cephalad pedicle screw.

Step 17k

Blocker Placement – Offset Lateral Connectors


Provisionally tighten the blocker in the saddle of the
lateral connector with the Blocker Holder.

29
Step 17l

Offset Connector Final Tightening


When construct assembly is complete, lateral
connectors and iliac screw blockers are final tightened
using the Final Screwdriver Shaft and Torque-Limiting
T-Handle.

The Counter-Torque Wrench Universal must be utilized


during final tightening.

Warning: The iliac screws and offset connectors provide


additional stabilization for an S1 screw. They should be used
only in conjunction with screw fixation in S1.

Step 17m
Note: Closed offset connectors are also available and should
be provisionally tightened to main construct rods prior to
provisionally locking the offset rod in the iliac screw tulip
head.

30
Transverse Connector Option

The SpeedLink II Transverse Connector System may be used at the surgeon's discretion if

additional construct stability is desired.

Step 18

Transverse Connector Placement (Optional)


Prior to placing the SpeedLink II Transverse Connector
onto the rod, ensure that the lateral cams are in the
“start” or unlocked position. If the cams are not in
this position, use the SpeedLink Final Driver Shaft
with the Straight Ratchet Handle to unlock the cams
with a counterclockwise turn. Load the SpeedLink II
System with the center set screw loose to allow free
range of motion and neutral placement of the implant
onto the rods.

Step 19

Lock the SpeedLink II System


Insert the SpeedLink Final Driver Shaft with the
Straight Ratchet Handle into the cam hex drive with
the indicator line pointing in the medial direction.
Rotate the driver to lock both lateral cams to the rods
(approximately ½ turn of each cam). Final tighten
the center set screw using the SpeedLink Final Driver
Shaft. Re-insert the Final Driver and use tactile
feedback to ensure that both lateral cams are in the
fully tightened position.

Warning: Do not use the Instinct Java Final Screwdriver Shaft


to lock the SpeedLink II Transverse Connector.

31
Bone Graft Placement

After all implants have been tightened and the construct completed, bone graft can be applied in
the normal manner.

32
Revision/Removal Option

Step 1

Blocker Removal
Place the Countertorque Wrench on the screw head
and insert the Final Screwdriver Shaft into each
blocker. Turn the Screwdriver counterclockwise to
remove the blocker.

Step 2

Rod Removal and Ring Alignment


Remove the rod and use the Blocker Holder tip to
mobilize the polyaxial screw head.

If the ring is not set in the rod axis, use the proximal
tip of the Blocker Holder to align the ring in the proper
direction.

33
Step 3

Screw Removal
Engage the Polyaxial 3.5mm Screwdriver tip into the
female star on the screw shank. Screw the sleeve into
the screw head (page 13) and turn the Screwdriver
counterclockwise to remove the screw from the
vertebra.

Repeat the procedure for all the screws of the


construct.

34
Instrument Disassembly and Cleaning

Polyaxial 3.5mm & Monoaxial Screwdrivers

Disconnect the handle from the Screwdriver by pulling


on the handle clamping collar.

Unlock the collet counterclockwise to disconnect it


from the external sleeve.

On the proximal side, remove the sleeve and the collet


from the driver shaft.

Note: After cleaning, lock the collet clockwise to prevent the


internal shaft from sliding out of the external sleeve when
handling.

35
Alligator Persuader

Disconnect the handle from the shaft by pressing on


the lateral button.

Remove the handle by pulling it.

Pull on the sleeve to remove it from the shaft and


unthread the collet completely. The prong on the
sleeve slides into the shaft groove for error-free
alignment.

The four parts remain disassembled for cleaning.

36
Instinct Java Kit Contents

Implants
Part Number Description Standard Kit Quantity

046W0AN00002 Blocker 36
046W0AN24525 Polyaxial Pedicle Screw Ø4.5 L25 2
046W0AN24530 Polyaxial Pedicle Screw Ø4.5 L30 2
046W0AN24535 Polyaxial Pedicle Screw Ø4.5 L35 4
046W0AN24540 Polyaxial Pedicle Screw Ø4.5 L40 4
046W0AN24545 Polyaxial Pedicle Screw Ø4.5 L45 2
046W0AN25525 Polyaxial Pedicle Screw Ø5.5 L25 2
046W0AN25530 Polyaxial Pedicle Screw Ø5.5 L30 2
046W0AN25535 Polyaxial Pedicle Screw Ø5.5 L35 4
046W0AN25540 Polyaxial Pedicle Screw Ø5.5 L40 6
046W0AN25545 Polyaxial Pedicle Screw Ø5.5 L45 6
046W0AN25550 Polyaxial Pedicle Screw Ø5.5 L50 6
046W0AN26530 Polyaxial Pedicle Screw Ø6.5 L30 4
046W0AN26535 Polyaxial Pedicle Screw Ø6.5 L35 6
046W0AN26540 Polyaxial Pedicle Screw Ø6.5 L40 8
046W0AN26545 Polyaxial Pedicle Screw Ø6.5 L45 8
046W0AN26550 Polyaxial Pedicle Screw Ø6.5 L50 8
046W0AN26555 Polyaxial Pedicle Screw Ø6.5 L55 4
046W0AN26560 Polyaxial Pedicle Screw Ø6.5 L60 2
046W0AN27530 Polyaxial Pedicle Screw Ø7.5 L30 2
046W0AN27535 Polyaxial Pedicle Screw Ø7.5 L35 4
046W0AN27540 Polyaxial Pedicle Screw Ø7.5 L40 6
046W0AN27545 Polyaxial Pedicle Screw Ø7.5 L45 6
046W0AN27550 Polyaxial Pedicle Screw Ø7.5 L50 6
046W0AN27555 Polyaxial Pedicle Screw Ø7.5 L55 2
046W0AN27560 Polyaxial Pedicle Screw Ø7.5 L60 2
046W0AN28530 Polyaxial Pedicle Screw Ø8.5 L30 2
046W0AN28535 Polyaxial Pedicle Screw Ø8.5 L35 2
046W0AN28540 Polyaxial Pedicle Screw Ø8.5 L40 4
046W0AN28545 Polyaxial Pedicle Screw Ø8.5 L45 4
046W0AN28550 Polyaxial Pedicle Screw Ø8.5 L50 2
046W0AN28555 Polyaxial Pedicle Screw Ø8.5 L55 2
046W0AN28560 Polyaxial Pedicle Screw Ø8.5 L60 2
046W0AN34525 Monoaxial Pedicle Screw Ø4.5 L25 2
046W0AN34530 Monoaxial Pedicle Screw Ø4.5 L30 2
046W0AN34535 Monoaxial Pedicle Screw Ø4.5 L35 2
046W0AN34540 Monoaxial Pedicle Screw Ø4.5 L40 4
046W0AN34545 Monoaxial Pedicle Screw Ø4.5 L45 4

37
Part Number Description Standard Kit Quantity

046W0AN35525 Monoaxial Pedicle Screw Ø5.5 L25 2


046W0AN35530 Monoaxial Pedicle Screw Ø5.5 L30 2
046W0AN35535 Monoaxial Pedicle Screw Ø5.5 L35 2
046W0AN35540 Monoaxial Pedicle Screw Ø5.5 L40 4
046W0AN35545 Monoaxial Pedicle Screw Ø5.5 L45 4
046W0AN35550 Monoaxial Pedicle Screw Ø5.5 L50 2
046W0AN36530 Monoaxial Pedicle Screw Ø6.5 L30 2
046W0AN36535 Monoaxial Pedicle Screw Ø6.5 L35 2
046W0AN36540 Monoaxial Pedicle Screw Ø6.5 L40 4
046W0AN36545 Monoaxial Pedicle Screw Ø6.5 L45 4
046W0AN36550 Monoaxial Pedicle Screw Ø6.5 L50 2
046W0AN36555 Monoaxial Pedicle Screw Ø6.5 L55 2
046W0AN36560 Monoaxial Pedicle Screw Ø6.5 L60 2
046W0AN37530 Monoaxial Pedicle Screw Ø7.5 L30 2
046W0AN37535 Monoaxial Pedicle Screw Ø7.5 L35 2
046W0AN37540 Monoaxial Pedicle Screw Ø7.5 L40 4
046W0AN37545 Monoaxial Pedicle Screw Ø7.5 L45 4
046W0AN37550 Monoaxial Pedicle Screw Ø7.5 L50 2
046W0AN37555 Monoaxial Pedicle Screw Ø7.5 L55 2
046W0AN37560 Monoaxial Pedicle Screw Ø7.5 L60 2
046W0AN38530 Monoaxial Pedicle Screw Ø8.5 L30 2
046W0AN38535 Monoaxial Pedicle Screw Ø8.5 L35 2
046W0AN38540 Monoaxial Pedicle Screw Ø8.5 L40 2
046W0AN38545 Monoaxial Pedicle Screw Ø8.5 L45 4
046W0AN38550 Monoaxial Pedicle Screw Ø8.5 L50 4
046W0AN38555 Monoaxial Pedicle Screw Ø8.5 L55 2
046W0AN38560 Monoaxial Pedicle Screw Ø8.5 L60 2
046W0AN50120 Straight Rod Ø5.5 L120 2
046W0AN50160 Straight Rod Ø5.5 L160 2
046W0AN50200 Straight Rod Ø5.5 L200 2
046W0AN50300 Straight Rod Ø5.5 L300 2
046W0AN50400 Straight Rod Ø5.5 L400 2
046W0AN50500 Straight Rod Ø5.5 L500 2
046W0AN51030 Pre-contoured Rod Ø5.5 L30 2
046W0AN51035 Pre-contoured Rod Ø5.5 L35 2
046W0AN51040 Pre-contoured Rod Ø5.5 L40 2
046W0AN51045 Pre-contoured Rod Ø5.5 L45 2
046W0AN51050 Pre-contoured Rod Ø5.5 L50 2

38
Implants cont'd.
Part Number Description Standard Kit Quantity

046W0AN51055 Pre-contoured Rod Ø5.5 L55 2


046W0AN51060 Pre-contoured Rod Ø5.5 L60 2
046W0AN51065 Pre-contoured Rod Ø5.5 L65 2
046W0AN51070 Pre-contoured Rod Ø5.5 L70 2
046W0AN51075 Pre-contoured Rod Ø5.5 L75 2
046W0AN51080 Pre-contoured Rod Ø5.5 L80 2
046W0AN51085 Pre-contoured Rod Ø5.5 L85 2
046W0AN51090 Pre-contoured Rod Ø5.5 L90 2
046W0AN51095 Pre-contoured Rod Ø5.5 L95 2
046W0AN51100 Pre-contoured Rod Ø5.5 L100 2
046W0AN51110 Pre-contoured Rod Ø5.5 L110 2
046W0AN51120 Pre-contoured Rod Ø5.5 L120 2
3308-35 SpeedLink II Transverse Connector, Small 1
3309-40 SpeedLink II Transverse Connector, Medium 1
3310-50 SpeedLink II Transverse Connector, Large 1
07.01260.001 Sterilization Case Lid 1
046W2AN00012 Implant container base 1
046W2AN00017 Implant container polyaxial caddy 1
046W2AN00018 Implant container monoaxial caddy 1
046W2AN00015 Implant container blocker caddy 1
046W2AN00019 Implant container rod tray 1

Iliac and Reduction Screw Module Implants


Part Number Description Standard Kit Quantity

046W0AN27570 Iliac screw Ø7.5 L70 2


046W0AN27580 Iliac screw Ø7.5 L80 2
046W0AN27590 Iliac screw Ø7.5 L90 2
046W0AN27510 Iliac screw Ø7.5 L100 2
046W0AN28570 Iliac screw Ø8.5 L70 2
046W0AN28580 Iliac screw Ø8.5 L80 2
046W0AN28590 Iliac screw Ø8.5 L90 2

39
Part Number Description Standard Kit Quantity

046W0AN28510 Iliac screw Ø8.5 L100 2


046W0AN44525 Reduction Polyaxial Pedicle Screw Ø4.5 L25 2
046W0AN44530 Reduction Polyaxial Pedicle Screw Ø4.5 L30 2
046W0AN44535 Reduction Polyaxial Pedicle Screw Ø4.5 L35 2
046W0AN45530 Reduction Polyaxial Pedicle Screw Ø5.5 L30 2
046W0AN45535 Reduction Polyaxial Pedicle Screw Ø5.5 L35 4
046W0AN45540 Reduction Polyaxial Pedicle Screw Ø5.5 L40 4
046W0AN45545 Reduction Polyaxial Pedicle Screw Ø5.5 L45 2
046W0AN46535 Reduction Polyaxial Pedicle Screw Ø6.5 L35 2
046W0AN46540 Reduction Polyaxial Pedicle Screw Ø6.5 L40 4
046W0AN46545 Reduction Polyaxial Pedicle Screw Ø6.5 L45 4
046W0AN46550 Reduction Polyaxial Pedicle Screw Ø6.5 L50 2
046W0AN46555 Reduction Polyaxial Pedicle Screw Ø6.5 L55 2
046W0AN47535 Reduction Polyaxial Pedicle Screw Ø7.5 L35 2
046W0AN47540 Reduction Polyaxial Pedicle Screw Ø7.5 L40 4
046W0AN47545 Reduction Polyaxial Pedicle Screw Ø7.5 L45 4
046W0AN47550 Reduction Polyaxial Pedicle Screw Ø7.5 L50 2
046W0AN47555 Reduction Polyaxial Pedicle Screw Ø7.5 L55 2
046W0AN75015 Open Offset 15mm Connector Ø5.5/Ø6.0mm 2
046W0AN75025 Open Offset 25mm Connector Ø5.5/Ø6.0mm 2
046W0AN75050 Open Offset 50mm Connector Ø5.5/Ø6.0mm 2
046W0AN75051 Open Right Angulated Offset 50mm Connector Ø5.5/Ø6.0mm 2
046W0AN75052 Open Left Angulated Offset 50mm Connector Ø5.5/Ø6.0mm 2
046W0AN76015 Closed Offset 15mm Connector Ø5.5/Ø6.0mm 2
046W0AN76025 Closed Offset 25mm Connector Ø5.5/Ø6.0mm 2
046W0AN76050 Closed Offset 50mm Connector Ø5.5/Ø6.0mm 2
046W0AN76051 Closed Right Angulated Offset 50mm Connector Ø5.5/Ø6.0mm 2
046W0AN76052 Closed Left Angulated Offset 50mm Connector Ø5.5/Ø6.0mm 2
07.01260.001 Sterilization Case Lid 1
046W2AN00015 Implant container blocker caddy 1
046W2AN00050 Iliac and Reduction Implant container base tray 1
046W2AN00051 Implant container reduction caddy 1
046W2AN00052 Implant container iliac caddy 1
046W2AN00053 Implant container offset connector insert 1

40
Also Available to Order
Part Number Description

Straight Rods – Ti
046W0AN50030 Straight Rod Ø5.5 L30
046W0AN50040 Straight Rod Ø5.5 L40
046W0AN50050 Straight Rod Ø5.5 L50
046W0AN50060 Straight Rod Ø5.5 L60
046W0AN50070 Straight Rod Ø5.5 L70
046W0AN50080 Straight Rod Ø5.5 L80
046W0AN50090 Straight Rod Ø5.5 L90
046W0AN50100 Straight Rod Ø5.5 L100

CoCr Rods
046W0AN52200 CoCr Rod Ø5.5 L200
046W0AN52300 CoCr Rod Ø5.5 L300
046W0AN52400 CoCr Rod Ø5.5 L400
046W0AN52500 CoCr Rod Ø5.5 L500

Reduction Polyaxial Screws


046W0AN44540 Reduction Polyaxial Pedicle Screw Ø4,5 lg 40
046W0AN44545 Reduction Polyaxial Pedicle Screw Ø4.5 L45
046W0AN45525 Reduction Polyaxial Pedicle Screw Ø5,5 lg 25
046W0AN45550 Reduction Polyaxial Pedicle Screw Ø5.5 L50
046W0AN45555 Reduction Polyaxial Pedicle Screw Ø5.5 L55
046W0AN46530 Reduction Polyaxial Pedicle Screw Ø6,5 lg 30
046W0AN46560 Reduction Polyaxial Pedicle Screw Ø6,5 lg 60
046W0AN47530 Reduction Polyaxial Pedicle Screw Ø7,5 lg 30
046W0AN47560 Reduction Polyaxial Pedicle Screw Ø7,5 lg 60

Java TL Tranverse Connectors


SN2023-0-52055 Transverse Connector Ø5,5 lg 52
SN2023-0-62055 Transverse Connector Ø5,5 lg 62
SN2023-0-72055 Transverse Connector Ø5,5 lg 72
SN2023-0-82055 Transverse Connector Ø5,5 lg 82

41
Also Available to Order
Part Number Description

Reduction Monoaxial Screws


046W0AN64525 Reduction Monoaxial Pedicle Screw Ø4,5 lg 25
046W0AN64530 Reduction Monoaxial Pedicle Screw Ø4,5 lg 30
046W0AN64535 Reduction Monoaxial Pedicle Screw Ø4.5 L35
046W0AN64540 Reduction Monoaxial Pedicle Screw Ø4.5 L40
046W0AN64545 Reduction Monoaxial Pedicle Screw Ø4.5 L45
046W0AN65525 Reduction Monoaxial Pedicle Screw Ø5,5 lg 25
046W0AN65530 Reduction Monoaxial Pedicle Screw Ø5,5 lg 30
046W0AN65535 Reduction Monoaxial Pedicle Screw Ø5.5 L35
046W0AN65540 Reduction Monoaxial Pedicle Screw Ø5.5 L40
046W0AN65545 Reduction Monoaxial Pedicle Screw Ø5.5 L45
046W0AN65550 Reduction Monoaxial Pedicle Screw Ø5.5 L50
046W0AN65555 Reduction Monoaxial Pedicle Screw Ø5.5 L55
046W0AN66530 Reduction Monoaxial Pedicle Screw Ø6,5 lg 30
046W0AN66535 Reduction Monoaxial Pedicle Screw Ø6.5 L35
046W0AN66540 Reduction Monoaxial Pedicle Screw Ø6.5 L40
046W0AN66545 Reduction Monoaxial Pedicle Screw Ø6.5 L45
046W0AN66550 Reduction Monoaxial Pedicle Screw Ø6.5 L50
046W0AN66555 Reduction Monoaxial Pedicle Screw Ø6.5 L55
046W0AN66560 Reduction Monoaxial Pedicle Screw Ø6.5 L60
046W0AN67530 Reduction Monoaxial Pedicle Screw Ø7,5 lg 30
046W0AN67535 Reduction Monoaxial Pedicle Screw Ø7.5 L35
046W0AN67540 Reduction Monoaxial Pedicle Screw Ø7.5 L40
046W0AN67545 Reduction Monoaxial Pedicle Screw Ø7.5 L45
046W0AN67550 Reduction Monoaxial Pedicle Screw Ø7.5 L50
046W0AN67555 Reduction Monoaxial Pedicle Screw Ø7.5 L55
046W0AN67560 Reduction Monoaxial Pedicle Screw Ø7.5 L60

42
Instruments
Part Number Description Standard Kit Quantity

046W1AN00300 SpeedLink Final Driver Shaft 1


046W1AN00500 Square Awl 1
046W1AN00505 Trial Rod 100 mm 1
046W1AN00506 Trial Rod 200 mm 1
046W1AN00520 Pedicular Sounder Straight Flexible 1
046W1AN00530 Pedicle Probe 1
046W1AN00540 Rod Bender 1
046W1AN00541 Rod Pusher 1
046W1AN00542 Rod Fork 1
046W1AN00550 Polyaxial 3.5 Screwdriver 2
046W1AN00551 Left Rod Bender 1
046W1AN00554 Right Rod Bender 1
046W1AN00560 Monoaxial Screwdriver 1
046W1AN00570 Straight Ratchet Handle 2
046W1AN00590 Blocker Holder 1
046W1AN00620 Rod Holder 1
046W1AN00640 Final Screwdriver Shaft 2
046W1AN00660 Counter Torque Wrench 1
046W1AN00745 Tap Ø4.5 mm 1
046W1AN00755 Tap Ø5.5 mm 1
046W1AN00765 Tap Ø6.5 mm 1
046W1AN00775 Tap Ø7.5 mm 1
046W1AN00800 Distraction Forceps 1
046W1AN00810 Contraction Forceps 1
046W1AN00820 Derotation Forceps 1
046W1AN00930 Alligator Persuader Handle 1
046W1AN00931 Alligator Persuader Sleeve 2
046W2AN00033 Instrument Container Upper Tray 1
046W2AN00034 Instrument Container Lower Tray 1
046W2AN00035 Instrument Container Base 1
046WNAN000T IFU, Instinct Java Instruments 1
07.01260.001 Instrument Container Lid 1

43
Iliac and Reduction Screw Module Instruments
Part Number Description Standard Kit Quantity

046W1AN00650 Torque-Limiting T-Handle 1


046W1AN00590 Blocker Holder 1
046W1AN00640 Final Screwdriver Shaft 2
046W1AN00661 Countertorque Wrench Universal 1
046W1AN00555 Polyaxial 3.5 Screwdriver Universal 2
046W1AN00565 Monoaxial Screwdriver Universal 1
046W1AN00875 Tap Ø7.5 mm 1
046W1AN00885 Tap Ø8.5 mm 1
046W1AN00670 Removal Tab Instrument 1
046W1AN00580 Ratcheting T-Handle 1
046W2AN00060 Iliac and Reduction Instrument Base 1
07.01260.001 Sterilization Case Lid 1

Also Available to Order – Instruments


Part Number Description

046W1AN00610 Derotation Forceps

44
Warnings and Precautions

Warnings
a. These devices must be implanted by surgeons who have been properly trained in spinal surgery. The
decision to implant them should only be made after taking into consideration the medical and surgical
indications, contraindications, side effects and precautions for use contained in these instructions
for use.

b. Do not reuse devices labeled for single use only even if a single-use device seems to be intact after
it has been removed. The potential risks related to re-use of the device that might affect the patient’s
health and safety include:

–– The transmission of infectious or viral agents. The cleaning and sterilization methods described in
these instructions for use do not apply to a device that has previously been used.

–– Loss of function and loss of mechanical characteristics of the implant (including possible rupture)
after the first implantation and following removal of the device.

c. Do not use if the packaging of the device is damaged.

d. Any unused, single-use device that has been exposed to blood, bone, tissue or body fluids must not
be reprocessed or resterilized and must be discarded.

e. Any contaminated implant should be treated as biological waste.

f. Use of the Instinct Java spinal fixation system must always be associated with a surgical procedure
intended to achieve fusion of the vertebral segment(s) being treated.

g. Surgeons must select the size of the implants based on the patient’s anatomy.

h. Surgeons must take into account the fact that the threaded ends of the screws may represent a risk for
soft tissue adjacent to the spine when they are implanted using a bicortical technique.

i. The Instinct Java spinal fixation system has not been evaluated for safety and compatibility in the
magnetic resonance (MR) environment and has not been tested for heating or migration in the MR
environment.

j. The use of transverse connectors in the construct could locally impede some medical procedures such
as lumbar punctures or spinal anaesthesia.

k. The safety and effectiveness of pedicle screw spinal systems have been established only for spinal
conditions with significant mechanical instability or deformity requiring fusion with instrumentation.
These conditions are defined in the product indications for use. The safety and effectiveness of these
devices for any other conditions are unknown.

l. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes
compared to those without a previous surgery

m. The iliac screws and offset connectors provide additional stabilization for an S1 screw. They should be
used only in conjunction with screw fixation in S1.

45
Precautions
PRE-OPERATIVE PRECAUTIONS

a. Patient’s weight: excessive weight, combined with other factors, entails additional stresses that may
cause implants to rupture.

b. Patient’s physical activity: intense physical activity during the fusion period increases the risk of
mobility, deformation or rupture of the implants.

c. Mental handicap: there is increased risk in patients who are unable to follow the surgeon’s
recommendations.

d. Physical handicap: this requires special attention, including in some cases modification of post-
operative physical therapy techniques.

e. Smoking: smoking has been shown to have negative effects on bone fusion, that contributes to the
risk of failure to consolidate. Smokers should be informed of this.

f. Surgeons should take into account the normal capacity of the Instinct Java spinal fixation system
depending on their surgical strategy for a given patient.

g. The implantation of pedicle screw spinal systems should be performed only by experienced spinal
surgeons with specific training in the use of this pedicle screw spinal system because this is a
technically demanding procedure presenting a risk of serious injury to the patient.

h. Some cleaning solutions, such as soda solutions or alkaline cleaners may damage the medical
devices. These solutions must not be used.

PERI-OPERATIVE PRECAUTIONS

Insertion of an implant must be done using the instruments designed and supplied for this purpose and
the technique specific to each device. The details of this insertion are found in the brochure entitled,
“Instinct Java: SURGICAL TECHNIQUE”, supplied by Zimmer Spine.

POST-OPERATIVE PRECAUTIONS

In order to avoid the absence of, or a delay in fusion, close follow-up of the patient for 2-4 months is
recommended. This period corresponds to formation of a bony callus. In order to avoid any failure of
the fixation and related clinical problems, it is also important to explain to patients the need to reduce
mechanical stresses applied to the implanted system. Implants may be removed once fusion has occurred
in order to avoid the “shielding effect” and to restore physiological mechanical loads to the bone
elements. This decision should be made based on the risk/benefit ratio for each patient. This is, as with all
patient care, left to the discretion of the operating surgeon.

46
Materials and Possible Side Effects

Materials
Screws, blocker and connectors from the Instinct Java spinal fixation system are made of a titanium alloy
Ti6Al4V (ISO 5832-3:1996 or ASTM F1472:2008) or Ti Ti6Al4V ELI (ASTM F136:2011). Rods are made of a
titanium alloy Ti6Al4V or Ti6Al4V ELI or cobalt-chromium-molybdenum alloy Cr28Co6Mo (ASTM-1537:11).

Note: Mixing of materials such as a titanium alloy and/or cobalt-chromium-molybdenum alloy with
stainless steel in the same fusion construct is forbidden due to a risk of corrosion.

47
Possible Side Effects
All potential side effects associated with spinal fusion surgery without medical device are possible. With
medical device, the list of potential side effects includes, but is not limited to:

a. The absence of, or a delay in, fusion.

b. Bending or fracture of the implant if fusion is absent or delayed due to prolonged exposure of the
osteosynthesis construct to repeated mechanical stresses.

c. Migration of the implant.

d. Loosening of the implant between two or more components of the assembly.

e. Allergy to the metal or hypersensitivity reaction to a foreign object.

f. Infection.

g. Localized decrease in bone density due to stress shielding by the implant.

h. Pain, discomfort or abnormal feeling due to the presence of the device.

i. Loss of the natural curvature of the spine.

j. Modification of the spinal geometric corrections, of the vertebral and/or intervertebral height and/or,
of the reduction in spinal deformities.

k. Vascular and/or neurological injury due to surgical trauma or the presence of the device.

l. Neurological lesions, leading to symptoms such as intestinal or bladder dysfunction, impotence, or


retrograde ejaculation.

m. Damage to a major blood vessel by compression, erosion or laceration that may lead to thrombosis or
hemorrhaging, either of which may lead to more or less severe disorders or to the death of the patient.

Additional surgery may be required to correct any of these potential side effects.

48
Solutions by the people of Zimmer Spine.

You are devoted to helping your patients reduce their pain and improve their lives.
And the people of Zimmer Spine are devoted to you. We are dedicated to supporting
you with best-in-class tools, instruments and implants. We are driven by the opportunity
to share our unrivaled education and training. We are committed partners who will
do everything in our power to assist you in your quest to provide the absolute best in
spinal care. And we can be counted on always to act with integrity as ethical partners
who are worthy of your trust. We are the people of Zimmer Spine.

Disclaimer

This document is intended exclusively for physicians and is not intended for laypersons.
Information on the products and procedures contained in this document is of a
general nature and does not represent and does not constitute medical advice
or recommendations. Because this information does not purport to constitute any
diagnostic or therapeutic statement with regard to any individual medical case, each
patient must be examined and advised individually, and this document does not
replace the need for such examination and/or advice in whole or in part.
Please refer to the package inserts for important product information, including, but
not limited to, contraindications, warnings, precautions, and adverse effects.

Manufacturer

Zimmer Spine
Cité Mondiale
23, parvis des Chartrons
33080 Bordeaux - France

Tel. +33(0)5 56 00 18 20
Fax +33(0)5 56 00 18 21

[Link]

© 2013 Zimmer Spine, Inc.

046E5AN00TEN - Jan.2013 - V6
Lit. N° 06.01811.012 - Ed 2013-01

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