SILO Spinal System

1 TSRH SILO Spinal System . Surgical Technique as described by: Marcel F. Dvorak, , FRCSC. Combined Neurosurgical and Orthopaedic Spine Program Vancouver General Hospital Associate Professor Department of Orthopaedics University of British Columbia Charles G. Fisher, , MHSc, FRCSC. Combined Neurosurgical and Orthopaedic Spine Program Vancouver General Hospital Assistant Professor Department of Orthopaedics University of British Columbia Rick C. Sasso, Indiana Spine Group Assistant Professor Clinical Orthopaedic Surgery Indiana University School of Medicine Indianapolis, Indiana Christopher I. Shaffrey, , FACS. Professor of Neurological Surgery Adjunct Professor Orthopaedic Surgery University of Virginia Charlottesville, Virginia Daniel J. Sucato, , Staff Orthopaedic Surgeon Texas Scottish Rite Hospital Associate Professor Department of Orthopaedic Surgery University of Texas at Southwestern Medical Center Dallas, Texas Jeffrey C.

2 Wang, Chief, Orthopaedic Spine Service Associate Professor Orthopaedic and Neurosurgery UCLA Comprehensive Spine Center UCLA School of Medicine Santa Monica, California T S R H S I L O S P I N A L S Y S T E M. Table of Contents Preface .. 2. Features and Benefits .. 3. Biomechanical Testing .. 4. Implant Overview .. 5. Instruments .. 7. NIM-SPINE Neural Integrity Monitor System .. 14. Pedicle Preparation .. 15. Screw Placement .. 18. Trauma T12 Burst Fracture Case .. 20. T12 to L1 Fracture Dislocation Case .. 30. Deformity Double Major Curve Correction Case .. 34. Kyphosis Correction Case .. 45. Degenerative L4 to S1 Fixation Case .. 51 . L5 Spondylolisthesis Reduction Case .. 60. Implant Explantation .. 62. Product Ordering Information .. 63. Important Product Information .. 68. 1. T S R H S I L O S P I N A L S Y S T E M. Preface Dear Colleagues: Despite the introduction and evolution of a wide variety of thoracolumbar rod and screw systems, the spine surgeon still faces many challenges in the operative care of patients requiring segmental Spinal instrumentation for trauma, deformity, tumor, and major degenerative instabilities.

3 The ability of ONE thoracolumbar rod and screw System to safely manipulate Spinal segments, reduce the rod to the screw or hook in a controlled manner, and correct significant deformities while maintaining strong implant/bone fixation has been lacking. We believe that the TSRH SILO Spinal System provides spine surgeons with a posterior fixation System with biomechanically-proven strength, flexibility, and ease of use, thus enabling the surgeon to efficiently deal with the severest of Spinal pathology. The side-opening and top-tightening aspects of the TSRH SILO Spinal System screws and hooks are designed primarily to simplify and enhance reduction capability in the high-demand . situation where deformity, due to trauma or other etiologies, provides significant reduction and fixation difficulties. Furthermore, we believe that the single-handed operation of the Rock-N- Roll Reducer and the flexibility of the Sagittal Adjusting Screw will facilitate the intraoperative reduction of the screw to the rod and will minimize the stresses that occur at the screw/bone interface during these reduction maneuvers.

4 We are optimistic and excited about the simplicity, versatility, and innovative capabilities of this new System that is targeted to provide intraoperative benefits to both the surgeon and the patient. It is our sincere hope that as we have, you will also be able to experience these benefits. Sincerely, Marcel F. Dvorak, , FRCSC Charles G. Fisher, , MHSc, FRCSC Rick C. Sasso, Christopher I. Shaffrey, , FACS Daniel J. Sucato, , Jeffrey C. Wang, 2. T S R H S I L O S P I N A L S Y S T E M. Features and Benefits Sagittal Adjusting Screw (SAS). - Enables 25 sagittal angulation - Provides the strength and manipulation capability of a Fixed Angle Screw with the forgiveness of a Multi Axial Screw - Allows for screw positioning and rod insertion at challenging angles - Sagittal forgiveness reduces the stress on the bone/screw interface that occurs during correction maneuvers and rod seating ( , the windshield wiper effect).

5 Rod Reduction Capabilities - Simplification of rod/screw reduction even over large trajectories - Single-hand operated Rock-N-Roll Reducer effortlessly reduces the rod to the screw or hook, thus enabling dorsal and lateral reduction - Allows vertebral segment manipulation and provisional fixation by a single surgeon Provisional Rod Capture - Single closure mechanism captures the rod into the head of the implant while still allowing for screw/vertebral body manipulation (derotation at the apex of scoliosis and kyphosis correction). - Set Screws can be preloaded, therefore eliminating the possibility of cross-threading during rod capture 3. T S R H S I L O S P I N A L S Y S T E M. Biomechanical Testing 4,000. Axial Grip 3,668. 3,500. 3,455. 3,361. 3,000 3,075. 2,500. Load (N). 2,239. 2,000. 1,750. 1,668. 1,500 1,480. 1,000. 500. 0 TSRH SILO TSRH SILO TSRH SILO MOSS SILHOUETTE XIA CLICK-X SR-90.

6 System System System Sagittal MIAMI System (Ti) System (Ti) System (Ti) System (Ti). Fixed Angle Multi Axial Adjusting System (Ti). Screw (Ti) Screw (Ti) Screw (Ti). Interconnection Fatigue Runout Moment (Nm). 0 TSRH SILO TSRH SILO MOSS SILHOUETTE XIA CLICK-X SR-90 . System System MIAMI System (Ti) System (Ti) System (Ti) System (Ti). Multi Axial Sagittal Adjusting System (Ti). Screw (Ti) Screw (Ti). 1,600. Static Flexion/Extension 1,400. 1,384. 1,200. 1,000. Load (N). 800. 600 650. 585 572. 482 494. 400. 368. 200. 0 TSRH SILO TSRH SILO MOSS SILHOUETTE XIA CLICK-X SR-90 . System System MIAMI System (Ti) System (Ti) System (Ti) System (Ti). Multi Axial Sagittal Adjusting System (Ti). Screw (Ti) Screw (Ti). TSRH SILO System is a trademark of Medtronic Sofamor Danek. The other products are third party trademarks and their use is not intended to communicate any license, sponsorship, or affiliation.

7 4. T S R H S I L O S P I N A L S Y S T E M. Implant Overview Versatility Multiple implant types provide versatility when planning surgical treatment as well as intraoperative flexibility to accommodate varying patient anatomy and pathologies Implant saddles are color-coded by screw diameter. Color-Coding Reference Sagittal Adjusting Screw Implant crowns are color-coded by screw diameter. Color-Coding Reference Multi Axial Screw Precut Precontoured Rod, Titanium Alloy Set Screw 25cm Rod, Titanium Alloy Lateral Connector Fixed Angle Screw 50cm Lined Rod, Titanium Alloy 5. T S R H S I L O S P I N A L S Y S T E M. Implant Overview (continued). Hook Color-Coding Reference Right-hand Hooks* magenta Left-hand Hooks* blue *Based on medial rod placement Blade Regions of Hook Type Placement Design Features Direction the Spine Hook throat ramp prevents the Thoracic Lamina T1 to T10 blade from encroaching into Hook the Spinal canal.

8 Bifid blade grasps the thoracic Pedicle Articular pedicle for increased stability. T1 to T10. Hook Process Shoe design provides stable fit to the lamina/pedicle. Blade geometry designed to Lamina T1 to L5 better fit the lumbar lamina to Laminar prevent hook pullout. Wider Hook blade width distributes forces Transverse evenly over a wider aspect of T1 to L5. Process the bone. Lamina T1 to L5. Narrow Narrower blade width Laminar minimizes metal volume in the Hook Transverse Spinal canal. T1 to L5. Process Can correct anatomic Lamina T1 to L5 malalignment between two Elevated laminae in the dorso/ventral Laminar plane. Designed to allow the Hook Transverse T1 to L5 implant to be placed closer to Process the midline. Lamina T1 to L5 Can be used to medialize or Lateral lateralize the rod in supralaminar Offset or infralaminar positions. Can Hook Transverse back up a pedicle screw at the T1 to L5 same level.

9 Process 6. T S R H S I L O S P I N A L S Y S T E M. Instruments Screw Preparation Awl (8880021). Thoracic Probe, Curved Lumbar Probe, Straight (7480112) (8880023). Dual Ended Feeler Probe Feeler Probe (8880036) (8880049). Cannulated Ratcheting Handle (8889082). Solid Tap, (8684500). Solid Tap, (836-015). Solid Tap, (836-016). Solid Tap, (836-018). 7. T S R H S I L O S P I N A L S Y S T E M. Instruments Screw Placement, Adjustment Manipulation Stick (8880100). Fixed Angle Screwdriver* Sagittal Adjusting Screwdriver*. (8880041) (8880048). *These drivers are interchangeable, unless utilizing image guidance technologies. Multi Axial Screwdriver Multi Axial Screw Height Adjuster (8880042) (8880046). Screw Positioner (8880035). 8. T S R H S I L O S P I N A L S Y S T E M. Instruments Rod Manipulation 20" Rod Template Rocker Reducer (808-575) (8880014). Medial Corkscrew Rod Pusher (8880065) (8880034).

10 Rock-N-Roll Reducer, Long, Left Rock-N-Roll Reducer, Long, Right (8880040) (8880039). Rock-N-Roll Reducer, Short, Right Rock-N-Roll Reducer, Curved, Right (8880030) (8880070). 9. T S R H S I L O S P I N A L S Y S T E M. Instruments Rod Manipulation Rod Gripper Rod Inserter (8880045) (8880029). In Situ Bender, Left In Situ Bender, Right (7480255) (7480260). Coronal Plane Bender, Left Coronal Plane Bender, Right (7480265R) (7480270R). Rod Rotation Wrench (7480285). French Bender (8880072). 10. T S R H S I L O S P I N A L S Y S T E M. Instruments Tightening Dual Ended Set Screw Starter (8880018). Dual Ended Set Screw Starter with Stops (8880019). Provisional T25 Driver (8880011). Extra Long Provisional T25 Driver (8880064). 11. T S R H S I L O S P I N A L S Y S T E M. Instruments Tightening Quick Connect T25 Driver Shaft 90 in-lb Torque Limiting Driver (8880007).