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Zimmer, Inc.

Zimmer® Anterior Buttress Plate System

Product Description

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.

Features

  • Innovative Plate Technology: pre-contoured plate conforms to local anatomy, low-profile and low-volume plate design minimizes tissue disruption, monoblock construction eliminates post-op disassembly due to fewer components, 22 or 26mm plate lengths.

  • Two Point Fixation: higher cantilever expulsion resistance.

  • Self-Drilling/ Self-Tapping Screws: ease of insertion, Ø4.3 and Ø4.5mm and in 20, 22 and 24mm lengths.

  • Graft Viewing Window: provides ideal graft/endplate interface visualization.

  • Proprietary Resilient Locking Arms: prevent screw back-out, single step locking, with three forms of feedback; visual, tactile and audible.

  • Serrated Surface: reduces risk of interoperative plate migration.

  • Self-Retaining All-In-One Drill Guide: plate control, ease of placement, soft-tissue protection.

ZS-SA0700-48_A


Device Description

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.

Indications

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

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:

  1. Active infectious process in the patient, particularly in or adjacent to the spine or spinal structures
  2. Morbid obesity.
  3. Pregnancy.
  4. Grossly distorted anatomy due to congenital abnormalities.
  5. Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery.
  6. Rapid joint disease, bone absorption, osteopenia, osteomalacia, or osteoporosis. Osteopenia or osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.
  7. Suspected or documented metal allergy or intolerance.
  8. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. 
  9. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcohol or drug abuse, occupation or life-style may interfere with their ability to follow post-operative instructions.
  10. Any time implant utilization would interfere with anatomical structures or expected physiological performance.
  11. Any case not needing a bone graft and fusion or where fracture healing is not required.

See also the WARNINGS, PRECAUTIONS and POSSIBLE ADVERSE EFFECTS section.

WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS

Warnings

  1. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. 
  2. Mixing of dissimilar metals can accelerate the corrosion process. Stainless steel and titanium implants must NOT be used together in building a construct. The Zimmer Anterior Buttress Plate System should not be used with components from any other system or manufacturer. As with all orthopedic implants, the Zimmer Anterior Buttress Plate System should not be reused after use as an implant or prior to sterilization.
  3. To avoid the risk of vascular injury, the plate MUST be placed caudal to the bifurcation of the great vessels.

Precautions

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.

Possible Adverse Effects

Potential complications and adverse effects for this system are similar to those of other spinal instrumentation systems, and include, but are not limited to:

  1. Early or late loosening of the components
  2. Disassembly, bending or breakage of any or all of the components
  3. Foreign body (allergic) reaction to the implants
  4. Infection
  5. Non-union (pseudarthrosis)
  6. Loss of neurological function, including paralysis (complete or incomplete), radiculopathy, dysesthesia, hyperesthesia, anesthesia, paresthesia, development or continuation of pain, numbness, neuroma, tingling sensation, dural tears, neuropathy, neurological deficits (transient, permanent, or delayed), reflex deficits, bilateral paraplegia, and/or arachnoiditis
  7. Hemorrhage, hematoma, seroma, embolism, edema, stroke, excessive bleeding, phlebitis, wound necrosis, or wound dehiscence
  8. Misalignment of anatomical structures or loss of spinal mobility
  9. Bone graft donor complications including pain, fracture or wound healing problems
  10. Atelectasis
  11. Retropulsion of graft
  12. Cessation of any potential growth of the operated portion of the spine
  13. Injury to the neck, including the esophagus, trachea, carotid artery, larynx, or laryngeal nerves
  14. Early or late hoarseness, dysphagia, or dysphonia
  15. Vascular damage resulting in excessive bleeding.
  16. Loss or impairment of bowel, sexual, and/or bladder function and other types of urological compromise.
  17. Fracture, damage, degenerative changes or instability of any bone above and/or below the level or surgery.
  18. Gastrointestinal system compromise
  19. Bone loss due to resorption or stress shielding
  20. Death

Additional surgery may be necessary to correct some of these potential adverse effects.