Surgical Technique - Euromed Implants GmbH · position is fixed by the Compressor-Simplex. Make sure not to loosen the compressor during this process. Distraction is accomplished

Surgical TechniqueVertfix Posterior Spinal System

Contents

Introduction...................................................................................................................1

Patient Positioning ........................................................................................................2

Subperiosteal Dissection ...........................................................................................2

Pedicle Entry Level ......................................................................................................3

Screw Selection and Insertion ....................................................................................4

Rod Selection ..............................................................................................................5

Rod Bending ................................................................................................................5

Rod Linkage and Set Screw Application .....................................................................6

Hooks ...........................................................................................................................7

Additional Surgical Options .........................................................................................8

Vertfix Posterior Spinal Implant Set ...............................................................................9

Vertfix Posterior Spinal Trays & Instruments Set ........................................................11

Note : This document is intended as a guide for the surgeon only. There are multiple techniques for the insertion of Vertfix Posterior Spinal System and as with any surgical procedure, a surgeon should be thoroughly trained and beware that this procedure is appropriate for the patient before proceeding.

(1)Vertfix Posterior Spinal System Surgical Technique

Introduction

EUROMED has combined biomechanical principles with high-tech production to create a new spinal stabilization system for Thoracic, lumbar or lumbar-sacral instrumentation using pedicle screws, pedicle-hooks, laminar-hooks for posterolateral spondylodesis, fractures, spondylolisthesis, stenosis of the spinal canal of the lower backbone, wear of vertebral discs, herniated vertebral discs, correction of failed fusion or pseudoarthrosis and in cases of unstable backbone conditions. Features and benefits of the system are the following,

• Low-profile system• Designed to minimize soft tissue interaction• No outer rings, bearings or not-pay off in the low profile of implants• Excellent anchoring stability of the implants guaranties lasting safety• Simplified handling of the instrumentation providing functional and save implants• Reduced instrument set to the essential tools for ergonomic and easy use• Post-operative treatment without corset• Compatibility to CTI-MRI for all implant components

Material Vertfix PS System is made of titanium Ti6Al4Veli in conformation with ASTM F 136 and ISO 5832-3 international standards, which has been specifically designed for the use in implant surgery. This alloy is characterized by demonstrating excellent biocompatibility, together with a high resistance to corrosion, superiormechanical strength and compatibility with current CTI and MRI scanning technology.

Vertfix Posterior Spinal System


Patient Positioning

The patient is positioned on the operating table in the prone position. The patient should be positioned to minimize intra-abdominal pressure to avoid venous congestion and excess intra-operative bleeding and allow adequate ventilation under anaesthesia. The patient’s hips should be extended to preserve lumbar lordosis for fusion instrumentation of the lumbosacral junction. The surgical approach is carried out through a standard midline incision to the spinal column over the anatomic position of the spinous process.The exposure of the spinous process should extend a additional level. The spinal column is then exposed in routine fashion by the surgeon and decompression is carried out as needed.

Subperiosteal Dissection Incise the midline of the lumbar spine under general anaesthesia. Perform subperioseal dissection of the musculature from the spinous processes. On both sides, dissection is carried out to the level of the transverse processes in the region of the intended fusion. Meticulously remove the musculature and the periosteum in the region of the segment to be fused.


Pedicle Entry Level

The pedicle entry point is intersected by the vertical line that connects the lateral edges of bony crest extension of the pars inter-articularis , and the horizontal line that bisects the middle of the transverse process. Anatomical variation in individual patients may cause slight differences in the entry site. These differences should be considered carefully and notes on the pre-operative MRI , CT images on the intra-operative x-rays.

A small rongeur or a burry may be used to decorticate the pedicle entry point.

The Adjustable Trocar Awl (Ref: EE0601S013N) is used to make a entry hole through the cortex at the pedicle entry point.


Additional info Control Probe - Type 1/2 (Ref: EE0801S013N-EE0801S014N) is used for confirmation of hole under image intensification.check for defects or perforations of the cortical wall.

The Pedicular Probe / Straight - Curved (Ref: EE0801N003N / EE0801N004N) is inserted through the entry hole and gently pressed into the pedicle canal. The probe is passed through the pedicle canal until the anterior cortex of the vertebra body is reached. Caution should be taken not to violate the anterior wall of the vertebral body or cortical wall.

After the use of the probe, the Pedicular Guide Wire (Ref: EE0801N001N) is used to confirm continuity of the cortical walls of the pedicle. It can also be used to palpate the inner surface of the pedicle canal to check for defects or perforations of the cortical wall.

The pedicle screws are available in several diameters and lengths. The appropriate screw length is determined by using the depth gauge on the Pedicular Probe / Straight - Curved (Ref: EE0801N003N / EE0801N004N).

Screw Selection and Insertion


Rod Selection

The rods are provided pre-cut in lengths ranging from 60 mm to 480 mm. The rod should extend approximately 5 millimetres beyond the outer edges of the proximal screw bodies of the most superior and most inferior pedicle screws.

Rod Bending

After the appropriate length of rod has been selected, Lordosis may be bent into the rod via the French Rod Bender (Ref: EE0901S002N) the polyaxial adjustability of lie system eliminates the need for precision bending of the rod. A simple Lordodic bent is sufficient and the amount of lordosis is based on the patients’ anatomy and the amount of reduction be achieved.

Pollyaxial Screw by Pollyaxial Screw Combine Screwdriver (Ref: EE0420N003N); Monoaxial Screw by Monoaxial Screwdriver (Ref: EE0400S023N) are screwed to the vertebral as desired depth, if screw do not get in to the vertebral easily; Universal Tap (Ref: EE0600N0...) could be used as starter.

Additional info If an additional screw adjustment is required after the mounting of the polyaxial screw, use the Pollyaxial Screw Screwdriver {Ref: EE0420S002N) with Modular T Handle might be used.


Additional info The Slotted Rod Bender / Left - Right (Ref: EE0901S014N-EE0901S013N) can be used to achieve final incremental correction maneuvers. Care should be taken to not make extreme bends as that can cause stress concentration and notching of the rod. After insertion of the Fusion screws and rod bending the rod is placed with Small Threaded Rod Clamp (Ref : EE0102S002N) in the Fusion screw housing.

Rod Linkage and Set Screw Application

The Rod Persuader (Ref: EE0413S030N) is used when additional force is needed to bring the rod to the pedicular screw. After the Persuader connect to the head of the pedicular screw. Turn the head of the Persuader clockwise, The Persuader is now linked to the ipedicular screw. From this position the rod can be pushed into the pedicular screw and the rod is now fully seated, allowing insertion of the Set Screw.

When all pedicular screws have been inserted and the rods have been placed in the head of the pedicular screw, the construct is then secured using set screws using procedure below for each screw. Load the Set Screw onto the Set Screw Driver. The Set Screw is firmly pressed onto one end of the Set Screw Driver. Introduce the Set Screw with the Set Screw Driver with T Handle through the Rod Persuader. Set Screws should be applied in sequential order and provisionally tightened. Final tightening can be applied if no additional alignments (Distraction, Compression) are needed.

Additional info The Simplex Spinal System uses the Set screw wich specially threaded. These threads allow that pedicular screw body closes when set screw is inserted. The Setscrew’s laser etched side is its upper side.


To remove the Rod Persuader, first take back the set screw driver, turn the head of the Rod Persuader counter clockwise while the head runs idle and pull the handle. Rotate the handle in any direction and remove the Rod Persuader. In the event the rod is forced down while tightening the Set Screw, be sure that the Set Screw is fully engaged into the pedicular screw head.

Additional info Extra caution is advised when:

1. The rod is not horizontally placed into the screw head2. The rod is high in the screw head.3. An acute convex or concave bend is contoured into the rod.

Additional info If required use Rod Rotation Forceps (Ref: EE0102S005N) to rotate the rod in its axis. To rotate the rod, fix the Hexagonal Wrench to the hexagonal tip of the rod and move the wrench up and down.

Hooks

The appropriate hook is chosen by a number of factors including patient anatomy, bone quality and the forces applied. Use the Hook Clamp (Ref: EE0101S031N) for transversal, laminar or pedicle hooks. Grip the hooks with the hook clamp and inserted into the desired site. Then mounting of rod and set screw is carried out in compliance with pedicular screw operations which is mentioned before.

Silicone Ring


Additional Surgical Options Distraction and Compression

After the construct has been properly assembled segmental compression and distraction is accomplished as needed to adjust frontal deformities or maintain plane deformities. Compression is accomplished using the Compressor (Ref: EE0304N010N). The Compressor fits on to the rod on the outside of the screws provisionally - tightened. Tighten one of the screws permanently. Drew provisionally-tightened screw toward the permanently-tightened screw. When the desired amount of compression has been achieved, the set screw of the provisionally-tightened screw is tightened using the Set Screwdriver with T Handle. Make sure not to loose the Simplex Large while the position is fixed by the Compressor-Simplex. Make sure not to loosen the compressor during this process.

Distraction is accomplished using the Distractor (Ref: EE0304N005N). The Distractor fits onto the rod on the inside of the secrews provisionally - tightened. Tighten one of the screws permanently. Push away the provisionally-tightened screw from the permanently - tightened screw. When the desired amount of distraction has been achieved, the set screw of the provisionally-tightened screw is tightened using the Set Screwdriver with T Handle. Make sure not to loosen the distractor during this process.

In the event that additional torsional stability is required, a cross connector may be utilized. After final tightening of the Fusion screws, the vertfix transverse link is assembled if desired. The transverse link assembly consists of one vertfix cross link shaft and two vertfix cross link hooks. There are six length of vertfix shafts, 40,50,60,70,80,90 mm. Once the desired location of the cross link has been determined, the appropriate vertfix cross link shaft length is selected. The vertfix shaft is assembled with one vertfix cross link hook and the hook-shaft assembly is placed over the rod with the vertfix set screw driver-small. The second cross link hook is then assembled on the cross link shaft and placed into position on the opposite rod Screwdriver for Set Secrew / Straight (Ref: EE0420S016N). The Compressor may be used to adjust and position the cross link on the rods. And the Set Screw Driver-Small is used to tighten each transverse hook set screw onto rods.


Vertfix Posterior Spinal Implant Set( EK0101N031N )

450

480

340

320

400

260

280

300

180

200

230

250

150

170

160

Rod140

80

60

120

100

90

130Cross Link Schaft

Cross Link H

ook

Rod C

ont.-Double

Rod C

ont.-Single

Sacral B

lock 4540

Sacral S

crew

40

50

60

70

80

90

35

39

42

11

41

40

43

44

45

466

38

38

TRAY-1

Set Screw

6,5x35

6,5x40

4,5x30

5,5x30

5,5x35

P

4,5x40

5,5x40

o l l xy a i a l

6,5x45

5,5x45

6,5x50

5,5x50

4,5x35

1

2

3

4

5

6

7

8

910

11

12

13

6,5x40

8x9

6,5x35

4,5x30

8x7

4,5x35

5x9

5x9long

n

4,5x40

5x7

5,5x30

M o

6,5x45

5,5x35

5x5

xo a i a l

5x7 L 5x7 R

5,5x455,5x40

5x9 L

6,5x50

5x7

5x7long

5x9 R

5,5x50

TRAY-2

14

15

16

17

18

19

20

21

22

23

24

2526

27

2829

30

3132

33

113534

36 37


No Ref. Number Description

1 EA0625T030N Vertfix Polyaxial Screw / Ti - Ø5.5 - 30








9 EA0600T010N Vertfix Set Screw





14 EA0604T030N Vertfix Monoaxial Screw / Ti - Ø4.5 - 30












26 EA0650T057N Vertfix Transversal Hook/ Ti - 5 X 7

27 EA0650T157N Vertfix Transversal Hook/ Ti - Long

28 EA0651T087N Vertfix Pedicular Hook / Ti - 8 X 7

29 EA0651T089N Vertfix Pedicular Hook / Ti - 8 X 9

30 EA0653T057N Vertfix Laminar Hook / Ti - 5 X 7



33 EA0654T059N Vertfix Laminar Hook / Ti - Long - 5 X 9

34 EA0659T002NVertfix Angled Laminar Hook / Ti - 5 X 9 - Left

35 EA0659T001NVertfix Angled Laminar Hook / Ti - 5 X 9 - Right

36 EA0657T002NVertfix Angled Laminar Hook / Ti - 5 X 7 - Left

37 EA0657T001NVertfix Angled Laminar Hook / Ti - 5 X 7 - Right

38

EA0123T001N Vertfix Rod / Ti - 60






















39

EA0670T040N Vertfix Cross Link Schaft / Ti - 40






40 EA0670T010N Vertfix Cross Link Hook/ Ti

41 EA0680T002N Vertfix Rod Connector - Double / Ti

42 EA0680T001N Vertfix Rod Connector - Single / Ti

43 EA0660T010N Vertfix Sacral Block / Ti

44 EA0660T035N Vertfix Sacral Screw / Ti - 35




24

25

26

28

29

30

31

32

26

27

2

5

1

8

3

4

9

33

76

10

11

12

13

14

15

16

1718

19

20

21

22 23

Vertfix Posterior SpinalTrays & Instruments Set ( EK0101N032N )


No Ref. Number Description

1 EE0413S001N Rod Pusher Lever

2 EE0421S001N Screw-Rod Holder Wrench-Pollyaxial

3 EE0400S023N Monoaxial Screwdriver

4 EE0420N003N Pollyaxial Screw Combine Screwdriver

5 EE0701S006N Hammer / 250 Gr

6 EE0901S013N Slotted Rod Bender / Right

7 EE0901S014N Slotted Rod Bender / Left

8 EE0420S019N T Handled Screwdriver For Set Secrew / Large

9 EE0413S030N Rod Persuader

10 EE0600N055N Universal Tap / 5.5



13 EE0420S013N Screwdriver For Set Secrew / Small

14 EE0400N050N Rod Pusher

15 EE0801N001N Pedicular Guide Wire

16 EE0420S017N Screwdriver For Set Secrew / Modular

17 EE0420S016N Screwdriver For Set Secrew / Straight

18 EE0420S002N Pollyaxial Screw Screwdriver

19 EE0801N003N Pedicular Probe / Straight

20 EE0801N004N Pedicular Probe / Curved

21 EE0601S013N Adjustable Trocar Awl

22 EE0801S014N Control Probe - Type 2

23 EE0801S013N Control Probe - Type 1

24 EE0101S031N Hook Clamp

25 EE0101S034N Cross Link Hook Clamp

26 EE0304N010N Compressor

27 EE0304N005N Distractor

28 EE0901S002N French Rod Bender

29 EE0102S005N Rod Rotation Forceps

30 EE0102S002N Small Threaded Rod Clamp

31 EE0101S035N Cross Link Saft Clamp

32 EE0421N004N Modular T Handle ( Torque ) - Pollyaxial

33 EE0413S003N Rod Pusher

Vertfix Posterior SpinalTrays & Instruments Set ( EK0101N032N )


Notes................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................

Euromed Implants GmbH

Wilhadi-Kirchhof 1321682 Stade

Germany

http://www.euromed-implants.de [email protected]

Tel. +49 (0) 4141 427744-5 Fax +49 (0) 4141 427744-7

Vertfix Posterior Spinal System, Surgical TechniqueRevision 2013-001

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Surgical Technique - Euromed Implants GmbH · position is fixed by the Compressor-Simplex. Make sure not to loosen the compressor during this process. Distraction is accomplished