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Cervical Disc System

MEDTRONIC POLAND Sp. Z.o.o.

Ul. Ostrobramska 101
04-041 WARSZAWA - POLAND
Tel: + 48 22 465 69 00 Fax: + 48 22 465 69 17

MEDTRONIC SOUTH AFRICA

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Alkotas Point
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PRESTIGE LP

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MEDTRONIC SOFAMOR DANEK

EUROPEAN SPINE CENTER
ZAC Paris Nord II
13, rue de la Perdrix
BP 59302
95940 ROISSY CDG Cedex - FRANCE
Tel: +33 1 49 38 80 00
Fax: +33 1 49 38 80 01
SOFAMOR SNC
RCS Bobigny B617 320 486 - NAF 331B

NOT FOR DISTRIBUTION IN THE UNITED STATES AND ITS TERRITORIES

REF EUPRESTST04B - MEDTRONIC SOFAMOR DANEK 05/2004 - all rights reserved

MEDTRONIC B.V.
Trg Drazena Petrovica 3/V
10 000 ZAGREB - CROATIA
Tel: +385 1 48 81 120 Fax: +385 1 48 44 060

SURGICAL TECHNIQUE

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Table of contents:

PREOPERATIVE MEASUREMENT

EXPOSURE / DISCECTOMY

2
3

ENDPLATE PREPARATION

PROSTHESIS PLACEMENT

EXPOSURE / DISCECTOMY
The Prestige LP Cervical Disc System is designed to
re-establish disc space height while maintaining normal
kinematics of the cervical spine in patients with symptomatic
cervical degenerative disc disease.
The Prestige LP features state-of-the-art technology built upon
more than 6 years of clinical history. The following surgical
technique describes the instrumentation and implantation for
the Prestige LP Cervical Disc.
The Prestige LP Cervical Disc System - leading the way in
maintaining motion in the cervical spine.

MULTI-LEVEL

PREOPERATIVE MEASUREMENT

PRODUCTS LIST

Using a computed tomography (CT) or magnetic resonance

image (MRI) obtained so that the slices are parallel to the
vertebral body endplates, determine the smaller of the two
vertebral body endplates at the target disc space. The use of CT
image is preferred. Do not include spurs or ridges that will be
removed in the subsequent burring/decompression process.

fig. 1a

fig. 1b

Determine the magnification factor of the image using the

Prestige LP Cervical Disc Template Set (figure 1a). Choose the
prosthesis template corresponding to the measured
magnification factor, and follow the instructions on the
template to select the prosthesis size. The selected size should
be used as a guide in selection of the size-specific
instrumentation and implant.
This templating process will estimate the appropriate footprint
of the implant, but not the height (figure 1b). The final selection
of implant size will be based on your clinical judgment, the disc
space preparation, and trialing.

PATIENT POSITIONING
The patient is placed in the supine position with the head and
neck in a neutral position. The posterior cervical spine should be
supported to establish and maintain this position (figure 2).

fig. 2

Note: Both shoulders may be pulled down and secured for

better visualization of the lower cervical spine on fluoroscopy if
necessary.

Typically, a transverse skin incision is made.

When approached, as much of the disc material and cartilage as
possible is removed using pituitaries, curettes and kerissons

To obtain a complete and thorough decompression, a vertebral

body or halter distractor may be used. Vertebral body
distraction pins are positioned midline in the vertebral bodies
adjacent to the discectomy. The distractor is placed over the
pins and the appropriate amount of distraction is applied. A
high-speed drill with a burr (match tip/round) may be utilized
for removal of the posterior disc and osteophytes to achieve
neural decompression. The posterior longitudinal ligament may
be carefully removed if necessary. Lightly burr the anterior
surface of the vertebral bodies to remove any soft tissue and
bony protrusions to create a flat surface (figure 3). Take care to
prevent excessive anterior bone removal.

fig. 3

DECOMPRESSION
Decompression remains the key element of the symptom relief.
Because this procedure and implant are designed to maintain
motion, complete decompression is essential (figure 4).

fig. 4

ENDPLATE PREPARATION

After the discectomy and decompression is complete, release

or remove exterior distraction devices. Using either a round or
cylindrical burr (surgeon preference), prepare the endplates so
that they are flat and parallel. Take care to preserve as much
cortical bone as possible. It is important to complete the
endplate preparation to the posterior aspects of the vertebral
bodies to ensure maximum implant-endplate interface (figure 5).
fig. 5

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CENTERING & ENDPLATE CUTTING

fig. 6

fig. 7

The appropriately sized Shim Distractor can be used during any

step of the procedure to assist in the introduction of
instruments into the disc space, or during endplate preparation,
should the disc space collapse without external distraction
(figure 6).

The appropriately sized Rasp can also be used, or used in

conjunction with a burr, for completing this step.
The appropriately sized Rasp should maximize endplate
contact. Introduce the rasp into the disc space with the positive
stop positioned superiorly (figure 7). The Rasp can be moved in
an in-and-out manner, with slight medial/lateral rocking. The
Handle Extension can be used to remove the Rasp if necessary.
Rasping will help remove any protrusions remaining after parallel
burring. The size dimensions of the Rasp head will precisely
match the endplate contacting dimensions of the implant
ensuring adequate preparation.

IMPLANT SIZE SELECTION

Once the endplates are prepared in a flat, parallel fashion, utilize
the appropriately sized Implant Trial to confirm the size of the
prepared disc space (figure 8). The size dimensions of the
Implant Trial head also precisely match the endplate-interfacing
dimensions of the implant.

fig. 8

The Implant Trial, which measures the disc space height and
depth, should fit snug, without distracting the disc space. If
more than gentle tapping is required to insert the Implant Trial
into the disc space, consider a smaller Trial or additional
endplate preparation. Verify fit of the Implant Trial with
fluoroscopy. It is important that the prepared endplates be in
complete contact with the flat portions of the Implant Trial and
that the posterior tip of the Trial reaches the posterior aspects
of the disc space.
The Implant Trial has four anterior tabs that match the anterior
tabs of the Prestige LP Cervical Disc. Double check the anterior
vertebral body surfaces to ensure no protruding bone interferes
with the placement of the Trial tabs flush with the anterior
surface.

Once the appropriate Prestige LP Disc size is determined

through the Implant Trial step, select the corresponding Rail
Cutter Guide to prepare the implant fixation channels in the
endplates. Gently impact the Rail Cutter Guide into the
prepared disc space. It is important that the Guide be centered
on the midline of the vertebral bodies. The Rail Cutter Guide
should be impacted until the four drill guide ports on the head of
the Guide touch the anterior surface of the spine (figure 9).

fig. 9

DRILLING
Attach the Rail Cutter Bit to the Drill Bit Handle. Insert the Rail
Cutter Bit into one port on the Rail Cutter Guide, resting the
shaft of the Bit in the corresponding slot at the top of the Rail
Cutter Guide, and drill the first fixation channel in the endplate.
While holding the Rail Cutter Guide firmly in place, remove the
drill bit and place a Temporary Fixation Pin in the channel. Drill
the next channel in the contra-lateral port. Place the second
Fixation Pin.

fig. 10

Repeat the process for the third, and finish by drilling the fourth
channel (figure 10). Remove the Fixation Pins and Cutter Guide.
Each properly prepared endplate should have two parallel
channels as shown. If this is not the case, double-check to
ensure that the endplates were properly paralleled and repeat
this step.

RAIL CUTTING
Align the four cutting blades of the Rail Cutter Punch into the
four ports made by the Rail Cutter Guide. Gently tap into disc
space until depth stops contact the anterior surface of the
spine. This should complete the preparation of the four channels
into the endplates as shown (figure 11).

fig. 11

Carefully remove any bone fragments from the disc space.

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PROSTHESIS PLACEMENT

Place the appropriately sized Prestige Disc in the corresponding

slot of the Loading Block. The ball portion of the implant should
be superior. Attach the Prestige LP Cervical Disc onto the
Implant Inserter by placing the four inserter prongs into the
ports on the anterior disc tabs and advancing the outer sheath
toward the disc (figure 12).

fig. 12

PRODUCTS LIST

IMPLANTS

With the ball portion of the prosthesis positioned superiorly,

align the Prestige LP Disc rails with the channels on the
endplates.

fig. 13

Insert the prosthesis into the prepared disc space. Gently tap
into place with a mallet until the anterior tabs come into contact
with the anterior surface of the vertebral bodies (figure 13).
A slight gap may remain between the tabs and anterior surface
on either the inferior or superior body if the anterior surfaces
are not exactly level. This is acceptable. Slide the outer sheath
back and gently remove the Inserter.

6971260 Disc Assembly 6X12

6971460 Disc Assembly 6X14

Utilize the Final Impactor to fully seat the Disc if necessary by

aligning it with the anterior aspects of the implant and gently
tapping with a mallet (figure 14).

6971114

Mallet

6971106

Shim Distractor

6971270
6971470
6971670
6971870

Following final Disc insertion, lateral and AP radiographs may be

taken to verify proper placement. Complete the surgery using
standard anterior cervical disc closure procedures.

6971480 Disc Assembly 8X14

6971680 Disc Assembly 8X16
6971880 Disc Assembly 8X18

ANCILLARY INSTRUMENTS

6971115

Handle Extension

6mm

6971107

Shim Distractor

7mm

6971108

6971226 Implant Trial

6971246 Implant Trial

6x12mm
6x14mm

6971227
6971247
6971267
6971287

Implant Trial
Implant Trial
Implant Trial
Implant Trial

7x12mm
7x14mm
7x16mm
7x18mm

6971248 Implant Trial

6971268 Implant Trial
6971288 Implant Trial

8x14mm
8x16mm
8x18mm

6971326 Rasp
6971346 Rasp

6x12mm
6x14mm

6971327
6971347
6971367
6971387

Rasp
Rasp
Rasp
Rasp

7x12mm
7x14mm
7x16mm
7x18mm

6971348 Rasp
6971368 Rasp
6971388 Rasp

8x14mm
8x16mm
8x18mm

6971126
6971146

6x12mm
6x14mm

6971127
6971147
6971167
6971187

Trial/Cutter Guide
Trial/Cutter Guide
Trial/Cutter Guide
Trial/Cutter Guide

7x12mm
7x14mm
7x16mm
7x18mm

6971148
6971168
6971188

8x14mm
8x16mm
8x18mm

6971426 Rail Punch

6971446 Rail Punch

6x12mm
6x14mm

6971427
6971447
6971467
6971487

Rail Punch
Rail Punch
Rail Punch
Rail Punch

7x12mm
7x14mm
7x16mm
7x18mm

6971448 Rail Punch

6971468 Rail Punch
6971488 Rail Punch

6971111

Rail Cutter Bit

1.5mm

6971112

Drill Bit Handle

6971150

Loading Block

6971156

Implant Inserter

6mm

6971157

Implant Inserter

6971160

Final Impactor

PLACEMENT VERIFICATION
fig. 14

Disc Assembly 7X12

Disc Assembly 7X14
Disc Assembly 7X16
Disc Assembly 7X18

Trial/Cutter Guide
Trial/Cutter Guide

Shim Distractor

Trial/Cutter Guide
Trial/Cutter Guide
Trial/Cutter Guide

8mm

MULTI-LEVEL

For the treatment of multiple levels, repeat the previously

described steps for each treated level.

EXPLANTATION
fig. 15
If explantation of the Prestige LP Cervical Disc is required,
separation of the implant from the endplate can be achieved
utilizing standard surgical instruments such as osteotomes and
forceps.

7mm

8x14mm
8x16mm
8x18mm

6971113

Temporary Fixation Pin 1.5mm

6971158

Implant Inserter

8mm