Ref: Q400-09T1 EBI Spine. September 05/VS02. c/o BIOMET Spain Orthopaedics, S.L.

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1 Ref: Q400-09T1 EBI Spine. September 05/VS02 c/o BIOMET Spain Orthopaedics, S.L.

2 EBI Omega 21 TM LP Since its introduction in 1996, and with thousands of patients treated so far, the EBI Omega 21 TM spinal system has been upgraded with improvements and implant additions, responding to the modern demands of advanced surgical techniques. INDEX The EBI Omega 21 TM LP system is a low profile pedicle screw system. Apart from a complete range of colorcoded fixed head screws, this low profile system comprises an ergonomically designed instrumentation in order to afford mechanical support and stability in vertebral fusion surgery. INDICATIONS The EBI Omega 21 TM LP spinal fixation device is indicated for the treatment of: Traumatisms: fractures, dislocations, disk herniation and generally any other injury causing instability. Degenerative diseases: both acute and chronic processes. Inflammatory disease: acute and chronic inflammation, often of a rheumatic nature. Tumor disease: malignant or benign tumors. Congenital pathologies: Although these are greatly varied, the most frequent example is spondylolisthesis, dealt with by fixation of the spinal elements with rods and screws. Surgical approach and preparation... Screw insertion... Rod application... Couplers application... Nut locking... Additional surgical options... Closure SYSTEM DESIGN FEATURES Low profile transpedicular system. Material made of Ti-6Al-4V titanium alloy. Simple and comfortable handling characteristics. Allows 3D corrections, such as fractures and deformities, thanks to its multidirectional connectors. Screws of optimum design, rounded tip, self-threading characteristics. Broad range of screws and rods. Color-coded implants for easy identification. Modular and ergonomic instrumentation. 100% compatibility with the classical EBI Omega 21 TM system. Allows hybrid constructions with the The EBI Omega 21 TM TOP system. This material is intended for the sole use of the physicians and the EBI SPINE sales force. It is not to be redistributed, duplicated or disclosed without the express written consent of EBI SPINE. EBI SPINE does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any implant procedure is responsible for determining and utilizing the appropiate techniques for implanting the prosthesis in each individual patient. EBI SPINE is not responsible for selection of the appropiate surgical technique to be utilized for an individual patient. See instructions for use for product information, including indications, contraindications, warning, precautions and potential adverse effects. This surgical technique has been revised and aproved by a Medical Doctor. 2 3

SURGICAL APPROACH AND PREPARATION The patient is placed in knee-elbow position or with cushions under the chest and pelvis, taking care to ensure the following: Abdominal decompression.

The incision must be sufficiently long to ensure exposure of the tips of the transverse processes and prevent the separators from interfering with pedicular screw placement.

In the lower lumbar spine, 5-10º angulation is required. At the thoracolumbar hinge, the orientation is more vertical (fig. 3).

3 SURGICAL APPROACH AND PREPARATION The patient is placed in knee-elbow position or with cushions under the chest and pelvis, taking care to ensure the following: Abdominal decompression. Preservation of physiological lordosis. The system implantation zone is the thoracolumbar region. The incision must be sufficiently long to ensure exposure of the tips of the transverse processes and prevent the separators from interfering with pedicular screw placement. The curved pedicular probe (ref ) or straight pedicular probe (ref ) is introduced in the pedicle untill reaching the vertebral body. In the lower lumbar spine, 5-10º angulation is required. At the thoracolumbar hinge, the orientation is more vertical (fig. 3). Pedicular probes are calibrated in order to help the screw lenght selection. Removal of the bone cortical layer is carried out to prepare the graft zone. Thoracic Vertebra fig.1 Lumbar Vertebra The pedicles are identified according to the habitual procedure (fig. 1). fig.3 The pedicle awl (ref ) or variable pedicle awl (ref ) is used to perforate the posterior cortical layer at the pedicle entry site (fig. 2). fig.2 fig.4 The X-ray probes (ref ) are positioned in the pedicles to allow identification of their correct position via fluoroscopy (fig. 4). 4 5

SCREW INSERTION Optionally, EBI Omega 21 TM screw drills of diameters 4.75 mm (ref. 2270-28), 5.5 mm (ref. 2270-30), 6.35 mm (ref. 2270-32), 7.5 mm (ref. 2270-34) and 8.

or T-handle (ref. 2270-02) (fig. 6). The tip of these drills is similar to that of the straight pedicle perforator.

591055IQL) to evaluate the hole and confirm that it is surrounded by cortical bone (medial, lateral and distal).

In the event expansive screws are inserted, use must first be made of the screw tap measuring 6.35 mm or 7.5 mm, depending on the size of the expansive screw (7.

Both the drills and taps are color-coded according to the selected screw diameter. fig.5 Racheting, quick connector straight handle fig.6 fig.

4 SCREW INSERTION Optionally, EBI Omega 21 TM screw drills of diameters 4.75 mm (ref ), 5.5 mm (ref ), 6.35 mm (ref ), 7.5 mm (ref ) and 8.5 mm (ref ) (fig. 5). Are assembled with the straight handle (ref ) (fig. 6) or T-handle (ref ) (fig. 6). The tip of these drills is similar to that of the straight pedicle perforator. The drill is advanced within the pedicle by twisting the ratchet wrench or T-wrench. fig.7 Before inserting the screws, the pedicular sound is introduced (ref IQL) to evaluate the hole and confirm that it is surrounded by cortical bone (medial, lateral and distal). All the bits are supplied calibrated, thereby allowing estimation of the length of the pedicle screw to be inserted. In the event expansive screws are inserted, use must first be made of the screw tap measuring 6.35 mm or 7.5 mm, depending on the size of the expansive screw (7.0 mm or 8.0 mm respectively), followed by the tap measuring 7 mm (ref ) or 8 mm (ref ). Both the drills and taps are color-coded according to the selected screw diameter. fig.5 Racheting, quick connector straight handle fig.6 fig.8 The EBI Omega 21 TM LP screws are inserted with the following instruments: Standar & spondylolisthesis; Screwdriver hexalobe 20 (ref ) and counter torque tube (ref ), together with the straight handle (ref ) or T-wrench (ref ). (fig. 7). All screws mandatory for expansive screws; For spondylolisthesis and expansive screws, the spondylolisthesis tube wench is used (ref ), together with the counter torque tube (ref ). (fig. 8) Quick connector T- handle 6 7

ROD APPLICATION COUPLERS APPLICATION When all the screws are in place, the required rod lenght is selected. To this effect use the malleable trial rod (ref.

11), and position them on the screws with the help of the rod forceps (ref. 2270-14). The rod pusher (ref.229009iql) or the X- ray probe (ref. 2270-54) (fig.

5 ROD APPLICATION COUPLERS APPLICATION When all the screws are in place, the required rod lenght is selected. To this effect use the malleable trial rod (ref IQL) to determine also the curvature (fig. 9). fig.9 Introduce the corresponding multidirectional couplers on the rod (fig. 11), and position them on the screws with the help of the rod forceps (ref ). The rod pusher (ref iql) or the X- ray probe (ref ) (fig.12), can help positioning the couplers correctly on the screws. fig.11 The rod is usually mounted medially with respect to the couplers to facilitate placement of the posterolateral graft. If necessary, the rod may be implanted laterally. Once the lenght has been selected, the rod is contoured using the French rod bender (229014IQL) (fig. 10). fig.10 fig

NUT LOCKING ADDITIONAL SURGICAL OPTIONS For nut locking, there are two ways of proceeding: Use the X-ray markers

The nut is threaded in the hexalobe shaft and then positioned through the head of each screw, which acts as a nut

13 Compression / distraction can be applied fixing the nuts at one side of the constrict with the compressor (ref.

6 NUT LOCKING ADDITIONAL SURGICAL OPTIONS For nut locking, there are two ways of proceeding: Use the X-ray markers as a locking nut guide and slightly tighten with the 9 mm hexagonal wrench ( ). (fig. 13). Use the hexalobe 20 nut guide (ref ), which is introduced in the 9 mm hexagonal wrench, together with the chosen handle. The nut is threaded in the hexalobe shaft and then positioned through the head of each screw, which acts as a nut guide (fig. 14). fig.13 Compression / distraction can be applied fixing the nuts at one side of the constrict with the compressor (ref ) or distractor (ref ). The desired maneuver is carried out, with final fixation of the remaining end (fig.15, fig. 16). Distractor-compressor for the rods is available (ref ), thus giving a fix poind and allowing compression and distraction maneuvers in long constructs. fig.16 fig.14 fig

CLOSURE Final closure is carried out with the hexagonal dynamometric wrench (ref. 2270-58) and double counter torque stabilizer (ref.

17 The operation is completed with placement of autologous bone or allograft in posterolateral position, with closure of the incision as usual. Final control is carried out via fluoroscopy.

When using the spondylolisthesis screws, breakage of the excess thread can be made with the spondylolisthesis tube wrench (ref. 2270-44) and extracted with the Hex 20 Nut guide (ref. 2270-48).

7 CLOSURE Final closure is carried out with the hexagonal dynamometric wrench (ref ) and double counter torque stabilizer (ref ), which has two functions: Positioning of the coupler on the rod (fig. 17). Counter-torque during tightening of the EBI Omega 21 TM LP screws (fig. 18). fig.17 The operation is completed with placement of autologous bone or allograft in posterolateral position, with closure of the incision as usual. Final control is carried out via fluoroscopy. It should be pointed out that the EBI Omega 21 TM LP is made of titanium alloy (Ti 6Al4V) which allows MRI diagnosis. When using the spondylolisthesis screws, breakage of the excess thread can be made with the spondylolisthesis tube wrench (ref ) and extracted with the Hex 20 Nut guide (ref ). After final tightening, small curvature corrections can be made with the right or left in situ benders. With the purpose of achieving an increased torsion stability for the construct, transverse connectors can be used, with the corresponding transverse rod. The associated instrumentation consists of the connector holder (ref ) and the hexagonal 20 screwdriver (ref ) and hexalobe 20 torque wrench (ref ) for final tightening. fig.18 To expand the expansive screws, the hexalobe 10 screwdriver (ref ) is employed once the construct has been fully locked. In case of expansive screw removal, the same screwdriver will unthread the pin and then, the screw will be extracted using the reverse method as for the For further information, see Reference Guide (Q400-10) 12 13

8 14 NOTES 15 COMPATIBILITY TABLE OMEGA 21 LP /50, /50, /65, /60, /60, /45, /55, /55, /50, / / /40/60/ /11/13/ / /40/ 45/50/55/60/ 70/ LP Multidirec. Coupling LP Screws LP Nuts LP Rods LP Transverse Rod Connector LP Transverse Rods LP Coaxial Rod Connector LP Parrallel Rod Connector LP Anterior Transverse Connector LP Sacrum Plate LP Sacrum Screws REF. Omega Multidirec. Couplings /45, /55, /65, /60, /60, /50, /50, , , /55, /55 Screws Nuts /25, /09 Rods Transverse Rod Connector /08 Transverse Rod /94 O-21 Plates O-21 Plate Nut O-21 Plate Washer

Y o u r Id e a s En g i n e e r e d t o Li f e

ISSYS LP Spinal Fixation System Surgical Guide Y o u r Id e a s En g i n e e r e d t o Li f e In t r o d u c t i o n ISSYS LP Sp i n a l Fixation System The foundation of the ISSYS LP Spinal Fixation System