Synthes EXPEDIUM VERSE System Manual
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Synthes EXPEDIUM VERSE System Manual

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EXPEDIUM VERSE
®
Spinal System
SYSTEM GUIDE

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Summary of Contents for Synthes EXPEDIUM VERSE

  • Page 1 EXPEDIUM VERSE ® Spinal System SYSTEM GUIDE...

  • Page 3: Table Of Contents

    FEATURES AND BENEFITS – Quick Stick Assembly and Attachment IMPLANT DESIGN – En Bloc Vertebral Body Derotation with the EXPEDIUM VERSE System INSTRUMENT DESIGN AND SET CONFIGURATION 6 – Segmental Vertebral Body Derotation SET CONTENTS with the EXPEDIUM VERSE System Compression and Distraction •...

  • Page 4: Product Overview

    Expedium 5.5: in this document we will be referring to the classic solid screw version as the EXPEDIUM VERSE Polyaxial Screw. The second is a more advanced, feature rich configuration which adds a fully cannulated shank with fenestrations and the Cortical Fix threadform at the proximal end of the screw: this version is known as the EXPEDIUM VERSE Fenestrated Cortical Fix Polyaxial Screw.
  • Page 5 For the first time in an EXPEDIUM 5.5 control of a monoaxial screw. Pedicle Screw, the EXPEDIUM VERSE System provides an X25 Drive Feature which allows for 43%** more torque to be delivered compared to the T20 Drive Feature provided in the EXPEDIUM 5.5 System.
  • Page 6 EXPEDIUM VERSE Fenestrated Cortical Fix Polyaxial Pedicle Screw The benefits of Polyaxial Screw plus… FIGURE 4 • The Fenestrated Cortical Fix • Earlier thread start compared to Polyaxial Screw is a fully cannulated standard EXPEDIUM, VIPER, and screw with fenestrations at the Screws distal end.
  • Page 7 (compared to standard EXPEDIUM and VIPER screws).* *Test data on file with DePuy Synthes Spine Standard Double-Lead Thread Integrates with the cancellous bone in the vertebral body.

  • Page 8: Implant Design

    Benefiting from the clinically proven design of the EXPEDIUM Using the EXPEDIUM VERSE System as a standalone system 5.5 and EXPEDIUM Favored Angle Screw Systems, each provides reduction capabilities at each operative level,...

  • Page 9: Instrument Design And Set Configuration

    INSTRUMENT DESIGN AND SET CONFIGURATION The EXPEDIUM VERSE Spine System has been developed in when compared to a traditional, instrument based system, close collaboration with spine surgeons with an aim to the EXPEDIUM VERSE System reduces the costs associated improve operating room efficiency by leveraging the unique with reprocessing and offers the potential to shorten the combination of features of the EXPEDIUM VERSE Implant.

  • Page 10: Set Contents

    20-65mm features which help surgeons to meet the challenge of complex pathologies. 20-65mm EXPEDIUM VERSE Implants are available in an extensive range 20-65mm of sizes providing surgeons thoracolumbar and pelvic fixation 30-100mm options for adolescent and adult pathologies.
  • Page 11 The EXPEDIUM VERSE SYSTEM is presented in four core cases. When using Fenestrated Cortical Fix Polyaxial Screws, an additional half tray of instruments is required for cement delivery. Pedicle Preparation and Screw and Rod Delivery Reduction, Derotation, Compression and Distraction...

  • Page 12: Surgical Technique

    Use the Ball Tip Feeler to verify pedicle cannulation and pedicle wall integrity. FIGURE 9 NOTE: Depth markings are provided in 10mm increments from 10mm through 60mm to provide depth of cannulation. DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 13: Tapping

    2750-10-140/160 Ball Tip feeler, Straight/Curved NOTE: In order to decrease the amount of torque EXPEDIUM VERSE Screws have a fully threaded, tapered tip required for large diameter screws, the degree of minimizing the need to tap. However, taps are provided for undertapping has been reduced for the 8mm tap.

  • Page 14: Screw Delivery

    Choose desired screw length and diameter. To improve surgical flow and minimize non-operative time, two poly FIGURE 14 drivers have been included in the set to enable concurrent screw loading and screw placement. DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 15: Loading The Expedium Verse Screw

    Secure the implant by sliding the Poly Driver Handle toward the implant and rotating it clockwise. FIGURE 15 NOTE: If it is desired to implant a EXPEDIUM VERSE Screw following removal of the extended tabs, the Poly Driver Shaft (removed from the Poly Driver Handle) or the X25 Inserter/Tightener can be used to implant the screw in the pedicle.

  • Page 16: Cement Delivery (Optional)

    If enhanced fixation in the pedicle and the vertebral body is confirm screw placement. desired, the EXPEDIUM VERSE Fenestrated Polyaxial Screw provides a fenestrated screw shank will accommodated the delivery of cement. Reference the prior surgical steps above for pedicle FIGURE 19 preparation and screw insertion.

  • Page 17: Cement Preparation

    NOTE: If there is any trouble inserting the cannula into the screw shank, ensure that the alignment device is properly threaded into the screw head. DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 18: Cement Delivery

    NOTE: It is essential to confirm that cement flow has stopped before disengaging the cement delivery system from the screw head. DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 19: Subsequent Level Augmentation

    Alignment Device and rotate to ensure any cement is removed. Insert the Mini-Stylet into the threaded tip of the Alignment Device. If cement remains in the device, repeat cleaning steps above or return it to DePuy Synthes Spine. DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 20: Rod Insertion

    Coronal In-Situ Bender, Left/Right 2997-04-195/200 Sagittal In-Situ Bender, Left/Right ROD CONTOURING The EXPEDIUM VERSE Spinal System is a 5.5mm diameter rod FIGURE 26 system. Titanium alloy (Ti) and Cobalt-Chromium alloy (CoCr) rods have been included in the set. Select the rod material of choice, cut, and contour the rod.

  • Page 21: Rod Placement

    Use the Rod Clamp to insert the rod into the openings of the EXPEDIUM VERSE Implants. Place the rod into the openings of the EXPEDIUM VERSE Implants using the sagittal profile of the rod to closely approximate the position of the polyaxial screw and begin sequential rod capture.

  • Page 22: Polyaxial To Monoaxial Conversion

    Counter Torque Handle The Correction Key was designed with the intent to convert the EXPEDIUM VERSE Pedicle Screw into a monoaxial implant while allowing the screw to articulate about the rod. Tighten the Poly Lock of the Correction Key with the Torque Limiting Handle while applying counter torque to lock the polyaxial head.

  • Page 23: Correction Maneuvers

    Consequently, the use of the EXPEDIUM VERSE Screw at each level permits a more uniform distribution of the forces required for correction, reducing the magnitude of stresses at the...

  • Page 24: Set Screw Insertion And Rod Capture

    The Correction Key and Unitized Set Screw are available designed with the intent to enhance tactile feedback in the EXPEDIUM VERSE System. The Correction Key during Correction Key or Unitized Set Screw (1997-21-000) allows for the independent locking of the engagement and during reduction while inducing a polyaxial head and the rod.
  • Page 25 The EXPEDIUM VERSE Pedicle Screw incorporates an FIGURE 40 FIGURE 41 alignment zone within the extended tab. This assists in aligning the threads of the Correction Key or Unitized Set Screw with the pedicle screw. It is recommended that a Quick Stick be used while inserting a Correction Key or Unitized Set Screw and during rod reduction.

  • Page 26: Rod Rotation

    NOTE: Reduction or extended tab screws such as EXPEDIUM VERSE Screws provide the additional benefit of accommodating a technique in which the rod is rotated from the coronal to sagittal plane prior to being fully reduced.

  • Page 27: Vertebral Body Derotation

    On the convex side monoaxial and uniplanar or polyaxial screws are placed into the pedicles. The EXPEDIUM VERSE Spinal System provides intraoperative conversion of polyaxial screws into monoaxial screws, providing a means to obtain derotational correction with a single implant type.

  • Page 28: Quick Stick Assembly And Attachment

    An audible click will indicate that the instrument has engaged the TOP NOTCH Feature. Finally, slide the Quick Stick Sleeve distally to lock the instrument to the implant. FIGURE 48 DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 29: En Bloc Vertebral Body Derotation

    En Bloc Vertebral Body Derotation with the EXPEDIUM VERSE System Facilitators must be applied to levels requiring derotation following the locking of the polyaxial heads. FIGURE 49 If application of a pull force is desired, Quick Sticks can be attached to the contralateral levels. An assistant pushes...

  • Page 30: Segmental Vertebral Body Derotation With The Expedium Verse System

    Poly Locks must be final tightened. Compression or distraction can be performed segmentally at this point if needed, as the EXPEDIUM VERSE Screws allow for parallel compression/distraction on the rod when the Correction Key Poly Lock is final tightened and the Rod Lock is loose.
  • Page 31 (concavity) may be simultaneously applied to affect maximal correction, just before the Rod Lock is tightened. If required, additional coronal correction can be achieved with the use of EXPEDIUM Coronal In-Situ Benders. DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 32 Poly Locks along the convex rod must be final tightened. Compression or distraction can be performed segmentally at this point if needed. The EXPEDIUM VERSE Screws allow for parallel compression/distraction on the rod when the Poly Lock is final tightened and the Rod Lock is loose.

  • Page 33: Compression And Distraction

    (FIGURE 55 B) Increasing Kyphosis / Decreasing Lordosis Ensuring the head polyaxialty has not been locked, applying distraction between adjacent screws will increase the distance between the posterior elements, increasing kyphosis / decreasing lordosis. DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 34 Optionally, the Rod Lock can also be final tightened at this time using the Torque Limiting Handle with counter torque instrumentation. FIGURE 57 FIGURE 58 DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 35: Final Tightening

    Inserter/Tightener attached to the Torque Limiting Handle. Final tightening of the Rod Lock is performed with the X25 Inserter/Tightener attached to the Torque Limiting Handle. Final tightening torque for the system is 80in-lb (9Nm). DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 36 Inserter/Tightener to first loosen the Rod Lock. Then, with the Poly Lock prior to retightening the Rod Lock. the counter torque assembly still in place, use the Key Inserter/Tightener to loosen the Poly Lock. DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 37: Tab Removal

    2997-04-315 EXPEDIUM Tab Breaker Cap A tab remover has been provided for removal of the EXPEDIUM VERSE Screw Reduction Tabs at the completion of the procedure. First, assemble the Tab Breaker by threading the Tab Breaker Cap into the Tab Breaker Body.

  • Page 38: Reduction With Flex Clip Reducer

    To retain reduction, insert a Correction Key or Unitized Set Screw through the Flex Clip Reducer. The Flex Clip Reducer can be removed by unthreading the Threaded Insert and compressing the Flex Clip to disengage the TOP NOTCH Feature. DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 39 DePuy Synthes EXPEDIUM VERSE System Guide ®...

  • Page 40: Product Catalog

    5mm Double Lead Tap, Cannulated 2997-04-135 T-Handle, Ratcheting 2997-04-960 6mm Double Lead Tap, Cannulated 2997-04-145 Pencil Handle (x3) 2997-04-970 7mm Double Lead Tap, Cannulated 2997-04-140 Tear-Drop Handle, Ratcheting (x2) 2997-04-980 8mm Double Lead Tap, Cannulated DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 41 Poly Driver, Handle (x2) 2997-04-155 Poly Driver, Shaft (x2) 2997-04-160 Poly Driver, Sleeve (x2) 2997-04-165 Head Adjuster 2997-04-180 Double End 5.5 Rod Hex Wrench 2997-04-175 Rod Clamp 5.5. (x2) 2997-04-330 Key Adjuster DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 42 2997-04-205 Facilitator (x6) Flex Clip Reducer Assembly Comprised of: 2997-04-355 Tab Ring (x4) 2997-04-270 Flex Clip Reducer, Flex Clip Flex Clip Reducer, Threaded Insert 2997-04-272 (2 piece) 2997-04-275 Flex Clip Reducer, Handle DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 43 2997-04-325 Torque Handle Adapter, 10mm Hex EXPEDIUM Tab Breaker Assembly Comprised of: 2997-04-310 EXPEDIUM Tab Breaker, Body 2997-04-315 EXPEDIUM Tab Breaker, Cap 2997-04-250 Distractor, 5.50mm 2997-04-255 Counter Torque Handle 2997-04-240 Compressor, 5.50mm DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 44 Sagittal In-Situ Bender, Right 2997-04-170 French Rod Bender CEMENT DELIVERY Contents ITEM NUMBER DESCRIPTION 2997-04-285 Alignment Device, Open 2997-04-295 Alignment Sleeve, Open 2797-26-402 Plunger 2797-26-403 Alignment Device Cleaning Stylet 2797-26-511 Mini Cleaning Stylet DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 45: Instruments

    ITEM NUMBER DESCRIPTION 2997-04-940 4.35mm Double Lead Tap, Cannulated 2997-04-950 5mm Double Lead Tap, Cannulated 2997-04-960 6mm Double Lead Tap, Cannulated 2997-04-970 7mm Double Lead Tap, Cannulated 2997-04-980 8mm Double Lead Tap, Cannulated DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 46: Handles & Adaptors

    HANDLES & ADAPTORS Modular Handles ITEM NUMBER DESCRIPTION 2997-04-135 T-Handle, Ratcheting 2997-04-140 Tear-Drop Handle, Ratcheting 2997-04-145 Pencil Handle 2997-04-320 Torque Limiting Handle, 80in-lb Adapters ITEM NUMBER DESCRIPTION 2997-04-325 Torque Handle Adapter, 10mm Hex DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 47: Screw Instruments

    Comprised of: 2997-04-215 Quick Stick, Sleeve 2997-04-217 Quick Stick, Tube Flex Clip Reducer, Assembly Comprised of: 2997-04-270 Flex Clip Reducer, Flex Clip 2997-04-272 Flex Clip Reducer, Threaded Insert 2997-04-275 Flex Clip Reducer, Handle DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 48: Rod Instruments

    Coronal In-Situ Bender, Left 2997-04-190 Coronal In-Situ Bender, Right 2997-04-195 Sagittal In-Situ Bender, Left 2997-04-200 Sagittal In-Situ Bender, Right Compression and Distraction ITEM NUMBER DESCRIPTION 2997-04-240 Compressor, 5.50mm 2997-04-250 Distractor, 5.50mm 2997-04-330 Key Adjuster DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 49: Tab Removal

    EXPEDIUM Tab Breaker, Cap CEMENT DELIVERY INSTRUMENTS ITEM NUMBER DESCRIPTION 2997-04-285 Alignment Device, Open 2997-04-295 Alignment Sleeve, Open Open Cannula 2797-26-500 (pre-packed sterile/single use) 2797-26-402 Plunger 2797-26-403 Alignment Device Cleaning Stylet 2797-26-511 Mini Cleaning Stylet DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 50: Cases And Trays

    Instrument 1 – Pedicle Prep 2997-04-802 Instrument 1 – Screw & Rod Insertion 2997-04-805 Graphic Case – Instrument 2 Instrument 2 – 2997-04-806 Reduction & Derotation Instrument 2 – 2997-04-807 Compression & Distraction DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 51 Instrument 3 – Rod Bending 2997-04-815 Graphic Case – Implant 1 Implant 1 – Rods, Keys, 2997-04-816 and Unitized Set Screws 2997-04-825 Screw Measuring Template 2997-04-830 Key and Unitized Set Screw Caddy 2797-92-109 Generic Outer Lid DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 52 ITEM NUMBER DESCRIPTION Graphic Case – 2997-04-835 Fenestrated Instruments 2997-04-840 Generic Outer Half Lid Graphic Case – 2997-04-845 Fenestrated Implant 1 2797-92-109 Generic Outer Lid DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 53: Implants

    5.5 EXP VERSE FEN SCR 5.0X60 199723565 5.5 EXP VERSE FEN SCR 5.0X65 199723570 5.5 EXP VERSE FEN SCR 5.0X70 199723575 5.5 EXP VERSE FEN SCR 5.0X75 199723580 5.5 EXP VERSE FEN SCR 5.0X80 DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 54 5.5 EXP VERSE FEN SCR 7.0X60 199723765 5.5 EXP VERSE FEN SCR 7.0X65 199723770 5.5 EXP VERSE FEN SCR 7.0X70 199723775 5.5 EXP VERSE FEN SCR 7.0X75 199723780 5.5 EXP VERSE FEN SCR 7.0X80 DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 55 5.5 EXP VERSE FEN SCR 8.0X60 199723865 5.5 EXP VERSE FEN SCR 8.0X65 199723870 5.5 EXP VERSE FEN SCR 8.0X70 199723875 5.5 EXP VERSE FEN SCR 8.0X75 199723880 5.5 EXP VERSE FEN SCR 8.0X80 DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 56 5.5 Ti EXP VERSE SCREW 5.0X45 1997-21-550 5.5 Ti EXP VERSE SCREW 5.0X50 1997-21-555 5.5 Ti EXP VERSE SCREW 5.0X55 1997-21-560 5.5 Ti EXP VERSE SCREW 5.0X60 1997-21-565 5.5 Ti EXP VERSE SCREW 5.0X65 DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 57 5.5 Ti EXP VERSE SCREW 7.0X45 1997-21-750 5.5 Ti EXP VERSE SCREW 7.0X50 1997-21-755 5.5 Ti EXP VERSE SCREW 7.0X55 1997-21-760 5.5 Ti EXP VERSE SCREW 7.0X60 1997-21-765 5.5 Ti EXP VERSE SCREW 7.0X65 DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 58 5.5 Ti EXP VERSE SCREW 8.0X100 1997-21-000 EXP VERSE CORRECTION KEY 1997-21-001 EXP VERSE UNITIZED SET SCREW 1797-62-480 Straight Rod, Hex End, Ti 480mm Straight Rod, Viper and Hex Ends, 1967-89-480 CoCr 480mm DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 59: Appendix

    Cobalt Chromium Alloy ELEMENT MINIMUM % MAXIMUM % Carbon — 0.14 Aluminum — — Lanthanum — — Chromium Molybdenum Nickel — Iron — 0.75 Silicon — Manganese — Nitrogen — 0.25 Cobalt Balance DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 60: Usage

    These DePuy Spine Spinal System components should not be used modes may include bone-metal interface failure, implant with components from other manufacturers. fracture, or bone failure. DePuy Synthes Companies EXPEDIUM VERSE System System Guide...

  • Page 61: Postoperative Mobilization

    DEVICES section of this insert. Any entity or condition that totally precludes the possibility of Please refer to EXPEDIUM VERSE IFU for complete listing of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative warnings, contraindications, and precautions.

  • Page 62: References

    6. Driscoll, M. M.-T. (2013). Biomechanical Assessment of Vertebral Rotation Based on Differential Rod Curvature Reduction Forces Measured During Scoliotic on the Lateral Radiograph. Spine, 37(18), E1120-E1125. Instrumentation Using Two Different Screw Designs. Spine Deformity, 94-101. DePuy Synthes Companies EXPEDIUM VERSE System System Guide...
  • Page 63 DePuy Synthes Companies EXPEDIUM VERSE System System Guide DePuy Synthes EXPEDIUM VERSE System Guide ®...
  • Page 64 When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM VERSE System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM VERSE systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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