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Zuma
™
Surgical Technique
Zuma Surgical Technique ™
The Zuma™ System features a unique one piece design that incorporates the benefits of an anterior fixation plate and a radiolucent interbody spacer. The system includes four screws and a locking cover to provide superior stability.
Step 1 - Patient Positioning
Position the patient in a slight Trendelenburg position.
Step 2 - Site Preparation
Access the appropriate level of the anterior or lateral column from L2 to S1 using standard approach techniques.
Step 3 - Trial and Rasp Trials and Rasps are available for each footprint in both 8 and 12 degrees of lordosis, and are undersized by ½ mm in height. All Trials and Rasps are color-coded to match the corresponding implant height.
Trial Insertion: Select the appropriate Trial and attach it to the Trial/Rasp Inserter by matching the threaded tip of the Trial/Rasp Inserter to the cavity on the back of the trial. Turn the thumb wheel clockwise until the trial is securely engaged. Insert the trial into the implantation site. A mallet may be used to advance the Trial into the space. Note: Plate Trials are available if needed. Plate trials are provided for each implant height.
Rasp Insertion: Select the appropriate Rasp and attach it to the Trial/Rasp Inserter by matching the threaded tip of the Trial/Rasp Inserter to the cavity on the back of the rasp. Turn the thumb wheel clockwise until the Rasp is securely engaged.
Insert the Rasp into the implantation site. A mallet may be used to advance the Rasp into the space.
Note: The T-Handle may be inserted into the top of the Trial/Rasp Inserter handle, if needed, to assist in backing the Trial/Rasp out of the implantation site.
Step 4 - Implant Selection
Select the appropriate size Zuma implant: implants are provided in three footprints: 26mm x 24mm, 32mm x 25mm, and 38mm x 26mm (width x depth). All footprints are available in heights of 10mm -18mm (2mm increments) and feature either 8º or 12º of lordosis. All implants are color-coded by height.
Step 5 - Bone Graft
Insert the Zuma implant into the appropriate Graft Packing Block. The provided Graft Packing Tamp can be used to firmly pack the Bone Graft into the implant cavity.
Step 6 - Implantation
Attach the Zuma implant to the Inserter by first matching the pin at the tip of the inserter with one of the small holes on the face of the plate. Next, thread the inserter into the implant by rotating the wheel at the top of the handle clockwise until the implant is secure.
rotate wheel clockwise
Insert the Zuma implant into the implantation site. A mallet may be used to advance the implant into the space. Once the desired placement is achieved, remove the Implant from the Inserter by rotating the wheel at the top of the handle counter-clockwise. rotate wheel counter-clockwise
Note: An Impactor is provided standard in the set. This may be used to adjust the implant if necessary.
Step 7 - Screw Hole Preparation Option 1 - Awl Prepare the screw insertion site by creating an entry hole using the Awl. At the entry hole location, insert the Awl through the Drill Guide shaft and apply a downward, twisting force until the sharp tip of the Awl penetrates the bone. Depth of penetration is limited to 20mm. Repeat this process for the remaining screw holes.
(Step 7 Continued)
Option 2 - Drill Straight and Flexible Drills are provided standard in the Zuma set. Select the appropriate Drill. Attach the Drill to the Quick Connect Drill Handle, insert through the Drill Guide shaft and advance the Drill until the stop hits the top of the Guide. Depth of penetration is limited to 20mm. Repeat this process for the remaining screw holes.
Step 8 - Screw Insertion The Zuma system offers 5.5mm diameter screws in three lengths: 20mm, 25mm and 30mm and 6.0mm diameter screws in three lengths: 25mm, 30mm, and 35mm. Straight and Flexible Screwdrivers are provided in the Zuma set. Select the appropriate 3mm Driver Shaft and attach it to the Ratcheting Handle. Select the appropriate screw length and load it onto the Driver. Insert the screw into the first screw hole. Repeat this process for the remaining screws.
Step 9 - Locking Cover Color Coded Locking Covers are provided for each of the corresponding implant heights. Select the appropriate Locking Cover. Using the 3mm Driver Shaft and the Torque Limiting Handle, screw the Locking Cover into the plate. This handle limits the maximum torque to the recommended 35 in-lbs.
Step 10 - Placement Verification Each Zuma Implant has four tantalum radiographic markers which aid in visualization. Below are three views which depict location of the markers. All markers are approximately 1mm from the edge of the implant.
Lateral View
Off- Lateral View
Anterior View
Catalog Implants HEIGHT LENGTH
Zuma
™
WIDTH
26mm x 24mm
32mm x 25mm
38mm x 26mm
Height
Lordotic Angle
Color
55-2610
55-3210
55-3810
10
8°
Purple
55-2612
55-3212
55-3812
12
8°
Green
55-2614
55-3214
55-3814
14
8°
Light Blue
55-2616
55-3216
55-3816
16
8°
Copper
55-2618
55-3218
55-3818
18
8°
Magenta
55-2710
55-3310
55-3910
10
12°
Purple
55-2712
55-3312
55-3912
12
12°
Green
55-2714
55-3314
55-3914
14
12°
Light Blue
55-2716
55-3316
55-3916
16
12°
Copper
55-2718
55-3318
55-3918
18
12°
Magenta
Note: Implants are measure by width x length x height
Variable Bone Screws • Single Lead • Self-Tapping • Titanium Alloy (Ti-6Al-4V ELI)
0º-10º Lateral Divergence
Part Number
Diameter
Length
55-5520
5.5
20
55-5525
5.5
25
55-5530
5.5
30
55-7025
6.0
25
55-7030
6.0
30
55-7035
6.0
35
18º + 10º
Zuma Trials and Rasps • Color-Coded by height • 1/2mm undersized from the Interbody device • Modular color coded
Optional Plate Trials • Color-Coded by height • Easily slide down the Trial/Rasp Inserter Shaft into position
Locking Covers • Color-Coded by height • Provide smooth surface with no additional profile
Instruments
Trail/Rasp Inserter 95-5105
Impactor 95-5103
Inserter 95-5105
Plate Inserter
T-Handle 95-5106
3mm Hex Shaft 95-5131
3mm Driver Shaft, Flexible 95-5133
Drill Guide 95-5160
Cannulated Guide 95-5165
Drill 95-5161
Drill, Flexible 95-5162
Awl 95-5170
Ratchet Handle 95-5510
Drill Handle, Quick Connect 95-5515
Graft Tamp 95-5190
Graft Packing Block 95-5191, 95-5192, 95-5193
Indications: When used as an intervertebral body fusion device, the Zuma System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autograft. Zuma is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. For additional information, please refer to the Instructions for Use, included in each product package.
Part #
Description
Location
Part #
Description
Location
95-5101
Inserter
1
95-5160
Drill Guide
9
95-5103
Impactor
2
95-5161
Drill
10
95-5105
Trial/Rasp Inserter
3
95-5162
Drill, Flexible
11
95-5106
T-Handle
4
95-5170
Awl
12
95-50xx
Plate Trial, 10mm – 18mm
5
95-5510
Ratchet Handle
13
95-0127
Torque Limiting Handle, 35 in-lb
6
95-5515
Drill Handle, Quick Connect
14
95-5131
3mm Hex Shaft
7
95-5535
EZ Out, 3mm Hex
15
95-5133
3mm Driver Shaft, Flexible
8
1
2
Level 1
3
5
6 4
11 10 13
8
7
15 12
14
Level 2 9
Sterility: This product is supplied “NON-STERILE” and must be sterilized before use. Pre-cleaning is not required. The recommended sterilization process is high temperature steam autoclave sterilization. The following validation cycle is recommended: The validation cycle is: Method: Steam / Cycle: Pre-vacuum / Temperatures and Exposure Times: 270° F (132° C) for 8 minutes
SeaSpine, Inc. 2302 La Mirada Drive Vista, CA 92081 P: 760.727.8399 F: 760.727.8809 www.seaspine.com
Based in Southern California, SeaSpine is dedicated to the advancement of spine surgery by providing innovative, cost-effective solutions to the surgical community.
mdi Europa GmbH Langenhagener Str. 71 30855 Hannover-Langenhagen Germany phone: +49-511-3908 9530 fax: +49-511-3908 9539 email: [email protected] internet: www.mdi-europa.com
SeaSpine is a registered trademark of SeaSpine, Inc. ©2008 by SeaSpine, Inc. All rights reserved. M-0059 REV C 4/10