Silony Medical VERTICALE Navigation Manual Download | Manualshive

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TABLE OF CONTENTS

Introduction / Preface ��

3

Indications / Contraindications ��

3

Preparation of Navigation system and instrumentation ��

4

Prerequisites on Navigation system and tracker ��

4

Assembly of instruments ��

5

Assembly of Navigated shaft instruments ��

5

Instrument registration instructions ��

6

Instrumentation / surgical steps ��

7

General Notes on use of Navigation instruments ��

7

Position and approach ��

8

Opening the cortex of the pedicle ��

8

Open the pedicle canal with a probe ��

8

Tapping (optional) ��

9

Selection of screw ��

9

Screw loading onto Navigated Screw Driver ��

10

Screw insertion ��

11

Further surgical steps �� 11

PRODUCT INFORMATION ��

PI 01

Instruments ��

PI 02

Implants ��

PI 03

The Navigation tracker shown in this instrumentation guide is representative for a variety of general navigation

tracker customary in the market�

NOTE:

The following guide is intended to familiarize you with the surgical procedure and use of the VERTICALE®

Navigation Instrumentation� This instrumentation guide supplements the guides for the VERTICALE® Screw Rod
System� Instruments from Silony Medical are processed, serviced, and cared for in accordance with the information
given in the instructions for use� Please read this guide and the instructions for use accompanying the implants
carefully before using the implant, and also pay particular attention to the information appended to this guide� This
guide does not replace briefing by a surgeon experienced in the instrumentation used in spinal surgery� We would be
happy to assist you in finding a hospital that provides an opportunity to observe surgical procedures�

NOTE:

Silony Medical is not a manufacturer of navigation systems or equipment� Please refer to the navigation

company’s software and user guides for instructions for use and training prerequisites on the navigation system�
Instructions for use and handling of any third-party navigation systems in combination with Silony instruments
are the responsibility of the hospital and navigation company� The navigation system should be set up per the
manufacturer’s instructions�

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Summary of Contents for VERTICALE Navigation

Page 1: ...VERTICALE Navigation INSTRUMENTATION GUIDE MADE IN GERMANY MADE IN GERMANY ...

Page 2: ... Instrumentation This instrumentation guide supplements the guides for the VERTICALE Screw Rod System Instruments from Silony Medical are processed serviced and cared for in accordance with the information given in the instructions for use Please read this guide and the instructions for use accompanying the implants carefully before using the implant and also pay particular attention to the inform...

Page 3: ...ort reduction head VERTICALE Polyaxial screw VERTICALE Monoaxial screw VERTICALE Uniplanar screw VERTICALE Revision Iliac screw VERTICALE MultiLocking screw INDICATIONS CONTRAINDICATIONS Please refer to the supplemental VERTICALE system guides and Instructions for Use for general procedural instructions indications contraindications and warnings Please consider the following additional information...

Page 4: ...he navigation system manufacturer If the respective third party instrument tracker set is not available at the hospital the VERTICALE Navigation Instruments cannot be navigated In the event that the respective third party instrument tracker set is unavailable a non navigated technique using fluoroscopy and respective Silony Medical instrumentation may be adopted as per Silony Medical Instrumentati...

Page 5: ...desired outer sleeve option onto the Basic Core 3 2 Instead of a non navigated driver shaft insert the VI 7130 SD Inner Shaft into the respective Screw driver Basic Core options Further instrument options can be found in the instrument list section at the end of this guide Further handle options can be found in the instrument list section at the end of this guide NOTE Do not use the same tracker t...

Page 6: ... in the navigation software that has been attached to the respective instrument Use the cross reference table at the end of this guide for any VERTICALE Navigation Instrument being used Upon successful registration the trajectory and location of the distal tip of the instrument or screw are visually represented within the software by the third party instrument or screw selected from the correspond...

Page 7: ...software use the next larger available size in diameter e g Ø 5 2 mm screws Software select Ø 5 5 mm screw projection At all times during use ensure the navigation tracker is visible to the camera of the respective navigation system in use For probes taps and the screw driver the navigation tracker will rotate around the instrument shaft Please hold the tracker with the hand for permanent camera v...

Page 8: ...canal with a probe 8 SILONY MEDICAL Instrumentation Guide Position and approach Assemble and register respective awl as described in assembly and registration section Please refer to general notes section prior to navigation Please refer to the VERTICALE OPEN Instrumentation Guide for information on opening the pedicle with an awl Further instrument options at the end of this guide VI 7024 VERTICA...

Page 9: ...Uniplanar screw VERTICALE Revision Iliac screw VERTICALE MultiLocking screw Assemble and register respective tap as described in assembly and registration section Please refer to general notes section prior to navigation Please refer to the VERTICALE OPEN Instrumentation Guide for information on tapping with solid taps or cannulated taps in combination with guide wires for guided insertion Further...

Page 10: ... VI 1130 by pressing the button on the middle part of the handle of the Screw driver basic core and pulling or pushing the driver shaft into its dedicated position 3 Loading screw in analogy to VI 1130 The VERTICALE pedicle screw driver tip is first inserted deeply into the inner drive feature of the screw shaft After that the internal thread of the screw head is connected to the external thread o...

Page 11: ...For insertion of additional screws follow the previous steps for the remaining screws NOTE The tip position of the navigated instrument with loaded screw must be verified for accuracy prior to use when using a navigation system Please refer to general notes section prior navigation NOTE Do not hold the middle handle of the screw driver basic core until disengaging the screw driver from the screw N...

Page 12: ...VERTICALE NAVIGATION PRODUCT INFORMATION The following section gives an overview on compatible instruments of the VERTICALE Screw Rod System ...

Page 13: ... Tap 6 2 7 2 mm Solera 6 5 mm Tap or Solera 7 5 mm Tap 9734302 or 9734303 9 VI 7089 VERTICALE Nav Tap 8 2 9 2 mm Solera 8 5 mm Tap 9734304 9 VI 7102 VERTICALE Nav Tap 10 2 mm Solera 8 5 mm Tap 9734304 9 VI 7130 VERTICALE Nav SD Inner Shaft Solera 4 75 Standard Driver or Solera 5 5 6 0 MAS Driver or Legacy PEEK Driver 9734279 or 9735023 or 9734278 5 10 VI 7145 VERTICALE Nav Tap 4 5 5 2 mm can Soler...

Page 14: ...Uniplanar Pedicle Screw cannulated shaft S VUS 4525 RS2 Ø 4 5 x 25 Uniplanar Pedicle Screw reduction solid shaft S VUS 4525 RK2 Ø 4 5 x 25 Uniplanar Pedicle Screw reduction cannulated shaft S VML 4525 S2 Ø 4 5 x 25 MultiLocking Pedicle Screw solid shaft S VML 4525 K2 Ø 4 5 x 25 MultiLocking Pedicle Screw cannulated shaft S VML 4525 RS2 Ø 4 5 x 25 MultiLocking Pedicle Screw reduction solid shaft S ...

Page 15: ...ion cannulated shaft S VML 4530 S2 Ø 4 5 x 30 MultiLocking Pedicle Screw solid shaft S VML 4530 K2 Ø 4 5 x 30 MultiLocking Pedicle Screw cannulated shaft S VML 4530 RS2 Ø 4 5 x 30 MultiLocking Pedicle Screw reduction solid shaft S VML 4530 RK2 Ø 4 5 x 30 MultiLocking Pedicle Screw reduction cannulated shaft S VPS 4535 S2 Ø 4 5 x 35 Polyaxial Pedicle Screw self tapping solid shaft Solera Ø 4 5 x 35...

Page 16: ... Screw self tapping reduction solid shaft S VFS 4540 RK2 Ø 4 5 x 40 Monoaxial Pedicle Screw self tapping reduction cannulated shaft S VUS 4540 S1 Ø 4 5 x 40 Uniplanar Pedicle Screw solid shaft S VUS 4540 K1 Ø 4 5 x 40 Uniplanar Pedicle Screw cannulated shaft S VUS 4540 RS2 Ø 4 5 x 40 Uniplanar Pedicle Screw reduction solid shaft S VUS 4540 RK2 Ø 4 5 x 40 Uniplanar Pedicle Screw reduction cannulate...

Page 17: ...S 4550 K2 Ø 4 5 x 50 Polyaxial Pedicle Screw self tapping cannulated shaft S VPS 4550 RS3 Ø 4 5 x 50 Polyaxial Pedicle Screw self tapping reduction solid shaft S VPS 4550 RK3 Ø 4 5 x 50 Polyaxial Pedicle Screw self tapping reduction cannulated S VFS 4550 S1 Ø 4 5 x 50 Monoaxial Pedicle Screw self tapping solid shaft S VFS 4550 K1 Ø 4 5 x 50 Monoaxial Pedicle Screw self tapping cannulated shaft S V...

Page 18: ...ulated shaft S VML 5225 S2 Ø 5 2 x 25 MultiLocking Pedicle Screw solid shaft S VML 5225 K2 Ø 5 2 x 25 MultiLocking Pedicle Screw cannulated shaft S VML 5225 RS2 Ø 5 2 x 25 MultiLocking Pedicle Screw reduction solid shaft S VML 5225 RK2 Ø 5 2 x 25 MultiLocking Pedicle Screw reduction cannulated shaft S VPS 5230 S2 Ø 5 2 x 30 Polyaxial Pedicle Screw self tapping solid shaft Solera 5 5 6 0 MAS Ø 5 5 ...

Page 19: ...shaft S VFS 5235 RF2 Ø 5 2 x 35 Monoaxial Pedicle Screw self tapping reduction cannulated and fenestrated shaft S VUS 5235 S1 Ø 5 2 x 35 Uniplanar Pedicle Screw solid shaft S VUS 5235 KF1 Ø 5 2 x 35 Uniplanar Pedicle Screw cannulated and fenestrated shaft S VUS 5235 RS2 Ø 5 2 x 35 Uniplanar Pedicle Screw reduction solid shaft S VUS 5235 RF2 Ø 5 2 x 35 Uniplanar Pedicle Screw reduction cannulated a...

Page 20: ...lyaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VPS 5245 RS3 Ø 5 2 x 45 Polyaxial Pedicle Screw self tapping reduction solid shaft S VPS 5245 RF3 Ø 5 2 x 45 Polyaxial Pedicle Screw self tapping reduction cannulated and fenestrated shaft S VFS 5245 S1 Ø 5 2 x 45 Monoaxial Pedicle Screw self tapping solid shaft S VFS 5245 KF1 Ø 5 2 x 45 Monoaxial Pedicle Screw self tapping cann...

Page 21: ...rated shaft S VML 5250 S2 Ø 5 2 x 50 MultiLocking Pedicle Screw solid shaft S VML 5250 KF2 Ø 5 2 x 50 MultiLocking Pedicle Screw cannulated and fenestrated shaft S VML 5250 RS2 Ø 5 2 x 50 MultiLocking Pedicle Screw reduction solid shaft S VML 5250 RF2 Ø 5 2 x 50 MultiLocking Pedicle Screw reduction cannulated and fenestrated shaft S VPS 5255 S2 Ø 5 2 x 55 Polyaxial Pedicle Screw self tapping solid...

Page 22: ...haft S VFS 5260 RF2 Ø 5 2 x 60 Monoaxial Pedicle Screw self tapping reduction cannulated and fenes trated shaft S VUS 5260 S1 Ø 5 2 x 60 Uniplanar Pedicle Screw solid shaft S VUS 5260 KF1 Ø 5 2 x 60 Uniplanar Pedicle Screw cannulated and fenestrated shaft S VUS 5260 RS2 Ø 5 2 x 60 Uniplanar Pedicle Screw reduction solid shaft S VUS 5260 RF2 Ø 5 2 x 60 Uniplanar Pedicle Screw reduction cannulated a...

Page 23: ...0 Polyaxial Pedicle Screw self tapping reduction cannulated shaft S VFS 6230 S1 Ø 6 2 x 30 Monoaxial Pedicle Screw self tapping solid shaft S VFS 6230 K1 Ø 6 2 x 30 Monoaxial Pedicle Screw self tapping cannulated shaft S VFS 6230 RS2 Ø 6 2 x 30 Monoaxial Pedicle Screw self tapping reduction solid shaft S VFS 6230 RK2 Ø 6 2 x 30 Monoaxial Pedicle Screw self tapping reduction cannulated shaft S VUS ...

Page 24: ...ction cannulated and fenestrated shaft S VPS 6240 S2 Ø 6 2 x 40 Polyaxial Pedicle Screw self tapping solid shaft Solera 5 5 6 0 MAS Ø 6 5 x 40 mm 55840006540 S VPS 6240 KF2 Ø 6 2 x 40 Polyaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VPS 6240 RS3 Ø 6 2 x 40 Polyaxial Pedicle Screw self tapping reduction solid shaft S VPS 6240 RF3 Ø 6 2 x 40 Polyaxial Pedicle Screw self tappin...

Page 25: ... RF2 Ø 6 2 x 45 Uniplanar Pedicle Screw reduction cannulated and fenestrated shaft S VML 6245 S2 Ø 6 2 x 45 MultiLocking Pedicle Screw solid shaft S VML 6245 KF2 Ø 6 2 x 45 MultiLocking Pedicle Screw cannulated and fenestrated shaft S VML 6245 RS2 Ø 6 2 x 45 MultiLocking Pedicle Screw reduction solid shaft S VML 6245 RF2 Ø 6 2 x 45 MultiLocking Pedicle Screw reduction cannulated and fenestrated sh...

Page 26: ... x 55 Monoaxial Pedicle Screw self tapping reduction cannulated and fenestrated shaft S VUS 6255 S1 Ø 6 2 x 55 Uniplanar Pedicle Screw solid shaft S VUS 6255 KF1 Ø 6 2 x 55 Uniplanar Pedicle Screw cannulated and fenestrated shaft S VUS 6255 RS2 Ø 6 2 x 55 Uniplanar Pedicle Screw reduction solid shaft S VUS 6255 RF2 Ø 6 2 x 55 Uniplanar Pedicle Screw reduction cannulated and fenestrated shaft S VML...

Page 27: ...ng reduction solid shaft S VPS 7225 RK3 Ø 7 2 x 25 Polyaxial Pedicle Screw self tapping reduction cannulated shaft S VFS 7225 S1 Ø 7 2 x 25 Monoaxial Pedicle Screw self tapping solid shaft S VFS 7225 K1 Ø 7 2 x 25 Monoaxial Pedicle Screw self tapping cannulated shaft S VFS 7225 RS2 Ø 7 2 x 25 Monoaxial Pedicle Screw self tapping reduction solid shaft S VFS 7225 RK2 Ø 7 2 x 25 Monoaxial Pedicle Scr...

Page 28: ...x 35 Polyaxial Pedicle Screw self tapping solid shaft Solera 5 5 6 0 MAS Ø 7 5 x 35 mm 55840007535 S VPS 7235 KF2 Ø 7 2 x 35 Polyaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VPS 7235 RS3 Ø 7 2 x 35 Polyaxial Pedicle Screw self tapping reduction solid shaft S VPS 7235 RF3 Ø 7 2 x 35 Polyaxial Pedicle Screw self tapping reduction cannulated and fenestra ted shaft S VFS 7235 S1...

Page 29: ... RF2 Ø 7 2 x 40 Uniplanar Pedicle Screw reduction cannulated and fenestrated shaft S VML 7240 S2 Ø 7 2 x 40 MultiLocking Pedicle Screw solid shaft S VML 7240 KF2 Ø 7 2 x 40 MultiLocking Pedicle Screw cannulated and fenestrated shaft S VML 7240 RS2 Ø 7 2 x 40 MultiLocking Pedicle Screw reduction solid shaft S VML 7240 RF2 Ø 7 2 x 40 MultiLocking Pedicle Screw reduction cannulated and fenestrated sh...

Page 30: ...x 50 Monoaxial Pedicle Screw self tapping reduction cannulated and fe nestrated shaft S VUS 7250 S1 Ø 7 2 x 50 Uniplanar Pedicle Screw solid shaft S VUS 7250 KF1 Ø 7 2 x 50 Uniplanar Pedicle Screw cannulated and fenestrated shaft S VUS 7250 RS2 Ø 7 2 x 50 Uniplanar Pedicle Screw reduction solid shaft S VUS 7250 RF2 Ø 7 2 x 50 Uniplanar Pedicle Screw reduction cannulated and fenestrated shaft S VML...

Page 31: ...ial Pedicle Screw self tapping reduction cannulated and fenestrated shaft S VFS 7260 S1 Ø 7 2 x 60 Monoaxial Pedicle Screw self tapping solid shaft S VFS 7260 KF1 Ø 7 2 x 60 Monoaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VFS 7260 RS2 Ø 7 2 x 60 Monoaxial Pedicle Screw self tapping reduction solid shaft S VFS 7260 RF2 Ø 7 2 x 60 Monoaxial Pedicle Screw self tapping reductio...

Page 32: ...ction cannulated and fenestrated shaft S VPS 7280 S2 Ø 7 2 x 80 Polyaxial Pedicle Screw self tapping solid shaft Solera 5 5 6 0 MAS Ø 7 5 x 80 mm 55840007580 S VPS 7280 KF2 Ø 7 2 x 80 Polyaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VPS 7280 RS3 Ø 7 2 x 80 Polyaxial Pedicle Screw self tapping reduction solid shaft S VPS 7280 RF3 Ø 7 2 x 80 Polyaxial Pedicle Screw self tappin...

Page 33: ...S 8245 S2 Ø 8 2 x 45 Polyaxial Pedicle Screw self tapping solid shaft Solera 5 5 6 0 MAS Ø 8 5 x 45 mm 55840008545 S VPS 8245 KF2 Ø 8 2 x 45 Polyaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VPS 8245 RS3 Ø 8 2 x 45 Polyaxial Pedicle Screw self tapping reduction solid shaft S VPS 8245 RF3 Ø 8 2 x 45 Polyaxial Pedicle Screw self tapping reduction cannulated and fe nestrated sha...

Page 34: ... reduction cannulated and fenestrated shaft S VPS 8260 S2 Ø 8 2 x 60 Polyaxial Pedicle Screw self tapping solid shaft Solera 5 5 6 0 MAS Ø 8 5 x 60 mm 55840008560 S VPS 8260 KF2 Ø 8 2 x 60 Polyaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VPS 8260 RS3 Ø 8 2 x 60 Polyaxial Pedicle Screw self tapping reduction solid shaft S VPS 8260 RF3 Ø 8 2 x 60 Polyaxial Pedicle Screw self t...

Page 35: ...ial Pedicle Screw self tapping reduction cannulated and fe nestrated shaft S VFS 8280 S1 Ø 8 2 x 80 Monoaxial Pedicle Screw self tapping solid shaft S VFS 8280 KF1 Ø 8 2 x 80 Monoaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VFS 8280 RS2 Ø 8 2 x 80 Monoaxial Pedicle Screw self tapping reduction solid shaft S VFS 8280 RF2 Ø 8 2 x 80 Monoaxial Pedicle Screw self tapping reducti...

Page 36: ... VFS 8210 RF2 Ø 8 2 x 100 Monoaxial Pedicle Screw self tapping reduction cannulated and fenestrated shaft S VIS 8210 S1 Ø 8 2 x 100 Iliac Screw solid shaft S VIS 8210 KF1 Ø 8 2 x 100 Iliac Screw cannulated and fenestrated shaft S VIS 8210 RS2 Ø 8 2 x 100 Iliac Screw reduction solid shaft S VIS 8210 RF2 Ø 8 2 x 100 Iliac Screw reduction cannulated and fenestrated shaft S VPS 9240 S2 Ø 9 2 x 40 Poly...

Page 37: ...pping reduction solid shaft S VPS 9250 RF3 Ø 9 2 x 50 Polyaxial Pedicle Screw self tapping reduction cannulated and fenestrated shaft S VFS 9250 S1 Ø 9 2 x 50 Monoaxial Pedicle Screw self tapping solid shaft S VFS 9250 KF1 Ø 9 2 x 50 Monoaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VFS 9250 RS2 Ø 9 2 x 50 Monoaxial Pedicle Screw self tapping reduction solid shaft S VFS 9250 ...

Page 38: ... 2 x 60 Iliac Screw reduction cannulated and fenestrated shaft S VPS 9270 S2 Ø 9 2 x 70 Polyaxial Pedicle Screw self tapping solid shaft Solera 5 5 6 0 MAS Ø 9 5 x 70 mm 55840009570 S VPS 9270 KF2 Ø 9 2 x 70 Polyaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VPS 9270 RS3 Ø 9 2 x 70 Polyaxial Pedicle Screw self tapping reduction solid shaft S VPS 9270 RF3 Ø 9 2 x 70 Polyaxial P...

Page 39: ...lid shaft S VPS 9290 RF3 Ø 9 2 x 90 Polyaxial Pedicle Screw self tapping reduction cannulated and fenestrated shaft S VFS 9290 S1 Ø 9 2 x 90 Monoaxial Pedicle Screw self tapping solid shaft S VFS 9290 KF1 Ø 9 2 x 90 Monoaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VFS 9290 RS2 Ø 9 2 x 90 Monoaxial Pedicle Screw self tapping reduction solid shaft S VFS 9290 RF2 Ø 9 2 x 90 Mon...

Page 40: ...reduction cannulated and fenestrated shaft S VIS 0240 S1 Ø 10 2 x 40 Iliac Screw solid shaft S VIS 0240 KF1 Ø 10 2 x 40 Iliac Screw cannulated and fenestrated shaft S VIS 0240 RS2 Ø 10 2 x 40 Iliac Screw reduction solid shaft S VIS 0240 RF2 Ø 10 2 x 40 Iliac Screw reduction cannulated and fenestrated shaft S VPS 0245 S2 Ø 10 2 x 45 Polyaxial Pedicle Screw self tapping solid shaft Solera 5 5 6 0 MA...

Page 41: ...crew self tapping reduction cannulated and fenestrated shaft S VFS 0255 S1 Ø 10 2 x 55 Monoaxial Pedicle Screw self tapping solid shaft S VFS 0255 KF1 Ø 10 2 x 55 Monoaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VFS 0255 RS2 Ø 10 2 x 55 Monoaxial Pedicle Screw self tapping reduction solid shaft S VFS 0255 RF2 Ø 10 2 x 55 Monoaxial Pedicle Screw self tapping reduction cannula...

Page 42: ...nulated and fenestrated shaft S VPS 0280 S2 Ø 10 2 x 80 Polyaxial Pedicle Screw self tapping solid shaft Solera 5 5 6 0 MAS Ø 10 5 x 80 mm 55840001580 S VPS 0280 KF2 Ø 10 2 x 80 Polyaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VPS 0280 RS3 Ø 10 2 x 80 Polyaxial Pedicle Screw self tapping reduction solid shaft S VPS 0280 RF3 Ø 10 2 x 80 Polyaxial Pedicle Screw self tapping re...

Page 43: ...0 S2 Ø 10 2 x 100 Polyaxial Pedicle Screw self tapping solid shaft Solera 5 5 6 0 MAS Ø 10 5 x 100 mm 55840001500 S VPS 0210 KF2 Ø 10 2 x 100 Polyaxial Pedicle Screw self tapping cannulated and fenestrated shaft S VPS 0210 RS3 Ø 10 2 x 100 Polyaxial Pedicle Screw self tapping reduction solid shaft S VPS 0210 RF3 Ø 10 2 x 100 Polyaxial Pedicle Screw self tapping reduction cannulated and fenestrated...

Page 44: ...or the USA and its territories D60063 a EN 12 01 2022 www silony medical com elabeling silony medical com contact Silony Medical GmbH Leinfelder Straße 60 70771 Leinfelden Echterdingen Germany Tel 49 711 78 25 25 0 Fax 49 711 78 25 25 11 ...

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