The Zimmer Anterior Buttress Plate System is designed to provide a low-profile, expulsion-resistant solution for anterior fusion procedures. This comprehensive system minimizes surgical steps through an All-In-One drill guide, proprietary Resilient Locking Arm Technology, and self-drilling bone screws.
The Zimmer Anterior Buttress Plate System is intended for anterior screw fixation to the L1 to S1 spine. The Zimmer Anterior Buttress Plate System consists of a variety of shapes and sizes of bone plates and screws. The components are manufactured from titanium alloy (Ti 6Al 4V ELI) as described by ASTM F136. Components of the Zimmer Anterior Buttress Plate System should not be used with components from any other system or manufacturer. The Zimmer Anterior Buttress Plate System components are provided non-sterile. The products need to be steam sterilized by the hospital prior to use.
The Zimmer Anterior Buttress Plate System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
Contraindications for the Zimmer Anterior Buttress Plate System are similar to those of other systems of similar design, and include, but are not limited to:
See also the WARNINGS, PRECAUTIONS and POSSIBLE ADVERSE EFFECTS section.
Implants and instruments are provided non-sterile and must be sterilized before use. Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert.
The Zimmer Anterior Buttress Plate System should only be implanted by surgeons who are fully experienced in the use of such implants and the required specialized spinal surgery techniques. Further, the proper selection and compliance of the patient will greatly affect the results. The surgeon should consider the patient conditions (e.g., smoker, malnutrition, obesity, alcohol and drug abuse, poor muscle and bone quality), which may impact system performance.
The Zimmer Anterior Buttress Plate System is only a temporary implant used for the anterior buttressing of a lumbar intervertebral bone graft. This device system is not intended to be used as a means of spinal support or fixation. Bone grafting must be part of the spinal fusion procedure in which the Zimmer Anterior Buttress Plate System is utilized. Use of this product without a bone graft or in cases that develop into a nonunion will not be successful. The spinal implant cannot stand body loads. In this event, bending, loosening, disassembly and/or breakage of the device will eventually occur.
After the spine is fused, these devices serve no functional purpose and should be removed. If the device is not removed following completion of its intended use, one or more of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain, (2) Migration of implant position possibly resulting in injury, (3) Risk of additional injury from postoperative trauma, (4) Bending, loosening and/or breakage, which could make removal impractical or difficult, (5) Pain, discomfort, or abnormal sensations due to the presence of the device, (6) Possible increased risk of infection, and (7) bone loss due to stress shielding. The surgeon should carefully weigh the risk versus benefits when deciding whether to remove the implant.
As with all orthopedic and neurosurgical implants, none of the Zimmer Anterior Buttress Plate System components should ever be reused under any circumstances. Risks associated with reuse include infection, non-union (pseudarthrosis), serious patient injury or death.
Due to the presence of implants, interference with roentgenographic, CT and/or MR imaging may result. The Zimmer Anterior Buttress Plate System has not been evaluated for safety and compatibility in the MR environment. The Zimmer Anterior Buttress Plate System has not been tested for heating or migration in the MR environment. It must be noted that there are several different manufacturers and generations of MRI systems available, and Zimmer Spine cannot make any claims regarding the safety of Zimmer Spine implants and devices with any specific MR system.
Physician Note: The physician is the learned intermediary between the company and the patient. The indications, contraindications, warnings, and precautions given in this document must be conveyed to the patient. If requested, additional information, including surgical technique manuals, may be obtained through corporate sales representatives.
Potential complications and adverse effects for this system are similar to those of other spinal instrumentation systems, and include, but are not limited to:
Additional surgery may be necessary to correct some of these potential adverse effects.