L8 Spine System SURGICAL TECHNIQUE. Add: No.1-8, Tianshan Road, Xinbei District, Changzhou, Jiangsu, China

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1 Add: No.-8, Tianshan Road, Xinbei District, Changzhou, Jiangsu, China Tel: Fax: Add: F25, Shanghai International Pharmaceutical Trad & Exhibition Tower, No,399, Jinqiao Road, Pudong District, Shanghai, China Tel: Fax: L8 Spine System SURGICAL TECHNIQUE

2 Contents Introduction Surgical Technique Instruments Implants L8 3 2

Introduction Introduction One of the products of the lowest

interference between screw heads at L5-S Does not impinge

thoracic spine and in smaller patients L8 Spinal Fixation

Top Loading Top Tightening Single Closure Mechanism Reduced

Reduce spread force Facility the plug driving Safer Nut

3 Introduction Introduction One of the products of the lowest profile and volume Facilitates preservation of facets No interference between screw heads at L5-S Does not impinge underlying bone Increased graft area Better fit for use in thoracic spine and in smaller patients L8 Spinal Fixation System is an advanced device based in L2 System. Simplity in operation, low profile, Universal application are the major features. Top Loading Top Tightening Single Closure Mechanism Reduced Number of Implants Revisable Vector Force Vector Force Reduce spread force Facility the plug driving Safer Nut Implant Head Nut Implant Head Thread Buttress Thread v Lumbar, Thoracic Sacral & Ilio-Sacral Degenerative Deformity Tumor/Trauma 2

The junction of the transverse process and the superior articular facet is the typical landmark for the entry site to the pedicle canal.

4 Surgical Technique Surgical Technique STEP 2 INSERT PEDICLE SCREW PATIENT POSITIONING STEP 2. IDENTIFICATION OF THE PEDICLES Accurate identification of the pedicle canal is necessary to ensure proper screw placement. The junction of the transverse process and the superior articular facet is the typical landmark for the entry site to the pedicle canal. However, anatomic variations in individual patients may cause slight differences in the entry site. These differences should be considered carefully and noted on the pre-operative MRI or CT images and on the intra-operative x-rays. The patient is placed on the operating table in the prone position.a spine surgery frame should be used which will avoid any pressure on the abdomen, there by avoiding vena caval compression. SURGICAL APPROACH Screw insertion should follow the angle of the pedicle canal. The surgical approach is carried out through a standard midline incision to the spinal column over the spinous processes. The incision should be long enough to ensure expose expected. The lumbar fascia is incised on the sides of each of the spinous processes. The supraspinous and interspinous ligaments should be preserved, particularly above the area of instrumentation, as these are important posterior stabilizers. Meticulous subperiosteal exposure of the posterior elements is performed. The paraspinal musculature is detached to the outer margins of transverse processes. Soft tissue and bony decompression are performed to relieve neurological STEP 2.2 MAKING THE ENTRANCE Make the entrance at the porper point with awl.then the straight awl is inserted along the direction of the pedicle into the vertebral body. 3 4

depth in the pedicle and help to determine appropriate screw length.

palpated with a probe to ensure that the walls of the pedicle have not been

Then the radiographic markers can be use to view the canals directions and

length determined, the pedicle screws are sequentially inserted using the

Insert the pedicle screw into the screwdriver and drive into L8

5 Surgical Technique Surgical Technique STEP 2.3 DETERMINING SCREW LENGTH The calibrations on the Straight Awl shaft show the depth in the pedicle and help to determine appropriate screw length. Having opened the channel of the pedicle, all four walls of the pedicle can be palpated with a probe to ensure that the walls of the pedicle have not been violated. Then the radiographic markers can be use to view the canals directions and depth. It can be use to select the appropriacte screw length as well. STEP 2.4 PPING THE PEDICLES STEP 2.5 SCREW INSERTION With the pedicle canals prepared and the pedicle screws length determined, the pedicle screws are sequentially inserted using the screwdriver. Insert the pedicle screw into the screwdriver and drive into L8 instrumentation offers two taps (5mm,6mm) which correspond to the bone screw diameters. The appropriate diameter tap is inserted through the pedicle and into the vertebral body. A probe can be used to follow the tap threads through the cancellous bone and palpate for any perforations in the pedicle walls. the pedicles following the previously prepared canal. When fully inserted, the pedicle screws should extend 50-80% into the vertebral body and be parallel to the endplates. The multi axial screw may be angled up to 25 medial and lateral to facilitate in the placement of the rod with minimal bending/contouring. Note: Tapping process is optional. 5 6

Surgical Technique Surgical Technique STEP 3 ROD INSERTION Usually, rod push forceps can be used to push the rod into screws head symply.

A rod template may be used to determine the rod contour needed for construct assembly.

The rod does not have to be precisely bent for attachment to the pedicle screws, especially for a single-level fusion.

construct by reducing the bending moment and thus reducing the stresses on the pedicle screws.

STEP 4 COMPRESSION/ DISTRACTION If compression or distraction will be used, it is carried out at this time.

Temporary fixation of the nut/screws may be done many times without damage to either the aut or the screw threads.

In either maneuver, the plug on one side of the motion segment should be provisionally tightened, with the other plug loose in the

Once satisfactory compression or distraction has achieved, final tightening may be performed.

6 Surgical Technique Surgical Technique STEP 3 ROD INSERTION Usually, rod push forceps can be used to push the rod into screws head symply. There are a various length of the rod in L8 system so that the operating of cutting rods is not necessary. A rod template may be used to determine the rod contour needed for construct assembly. The rod may be bent into lordosis using the rod bender. The rod does not have to be precisely bent for attachment to the pedicle screws, especially for a single-level fusion. However, bending the rod to an appropriate lordotic curvature lowers the profile of the implants and improves the biomechanics of the construct by reducing the bending moment and thus reducing the stresses on the pedicle screws. A lordotic bend in the rod also allows an element of medial or adjustment on a multi-level lateral construct. STEP 4 COMPRESSION/ DISTRACTION If compression or distraction will be used, it is carried out at this time.the provisional plug driver may be used to maintain temporary locking and security of the rod/screws construct. Temporary fixation of the nut/screws may be done many times without damage to either the aut or the screw threads. Compression or distraction may be performed. In either maneuver, the plug on one side of the motion segment should be provisionally tightened, with the other plug loose in the structure. Compression or distraction will occur against the provisionally tightened the auts. Once satisfactory compression or distraction has achieved, final tightening may be performed. Note: Distraction is seldom indicated other than while performing a PLIF because of the increased risk of implant failure, pseudoarthrosis an creating segmental kyphosis. After the rod is place near to the top of the pedicle screw head,the reduction forceps is used for the rod reduction. The reduction forceps cover the screw s head and clip it, The handles of the reducer are parallel to the rod. With the grasping the reducer handles slowly, the sleeve of the reducer will slide down and seat the rod. The elastic nuts holder with the nut is then inserted through the reduction forceps tube into the head of the pedicle screw. 7 8

Surgical Technique Surgical Technique STEP 5 DEVELOPING THE FUSION BED The facet joint capsules are removed.

The transverse processes, sacral alae and the lateral walls of the facet joints are decorticated.

STEP 7 BONE GRAFTING, CROSSLINK SYSTEM AND CLOSURE Decortication and bone grafting can also now perform. Wound closure is then performed in the customary manner.

7 Surgical Technique Surgical Technique STEP 5 DEVELOPING THE FUSION BED The facet joint capsules are removed. The articular cartilage of the facet joints is removed and cancellous bone is exposed. Cancellous bone graft is packed into each facet joint. The transverse processes, sacral alae and the lateral walls of the facet joints are decorticated. Corticocancellous bone graft are firmly pressed onto the bone fusion bed. STEP 7 BONE GRAFTING, CROSSLINK SYSTEM AND CLOSURE Decortication and bone grafting can also now perform. Wound closure is then performed in the customary manner. Transverse connector can be assembled in this time. STEP 6 FINAL TIGHTENING While the hex driver is inserted through the cannulation of the counter torque, the T-handle provides adequate leverage for tightening the nut. The handle of the counter torque device should be held firmly to prevent torquing of the construct while the nut is secured and long arm of the reduction screws sheared off. 9 0

8 Instruments Implants L8 Spine Implants L8 Spine Instruments Set Product Code Product Description Material Remark Instrument Code Contents Quantity L8 Spine Instruments Set L8 Spine Instruments Set(empty) L8 Spine Instruments Case L8 Spine Instruments Tray T-Handle with Quick Coupling, 8.0 Awl Straight Awl Curved Awl Probe 5mm Tap 6mm Tap 3mm Screwdriver Rod Template 25mm Rod Template 50mm Rod Pusher Rod Rotation Wrench Rod Holder, 5.5mm Rod Bender Compressor Rod Holder Forceps Break Off Iron Distractor Nuts Screwdriver, for L8 Monoaxial Screwdriver, for L8 Multiaxial Screwdriver, for L8 Nuts Holder, elastic, for L8 Counter Torque, for L8 Break Off Protector, for L8 Rod Push Forceps, for L8 Reduction Forceps, for L8 Marker Inserter Marker, left Marker, right Bending Iron, left Bending Iron, right Ratchet Handle Anterior Distraction Rod, for L8 Crosslink Hooks Holder L8 Spine implants Case : Customer Made 2 *

Implants Implants L8 L8 32237025 32237030 32237035 32237040 32237045 32237050 32237055 32238025 32238030 32238035 32238040 32238045 32238050 32238055 32239025 32239030 32239035 32239040 32239045

9 Implants Implants L8 L Product Code Product Description Material Remark Product Code Product Description Material Remark * : Customer Made * : Customer Made 3 4

10 Implants Implants Product Code Product Description Material Remark Product Code Product Description Material Remark mm Crosslink Bar 55mm Crosslink Bar 60mm Crosslink Bar 65mm Crosslink Bar 70mm Crosslink Bar 75mm Crosslink Bar 80mm Crosslink Bar L8 Nuts for all L8 screws Crosslink Hooks * : Customer Made * : Customer Made 6

operative technique Universal Application

operative technique Universal Application Introduction Introduction Building upon the design rationale of the Xia Spinal System, the new Xia Spinal System represents the latest advancement in spinal implant