ZIMMER

3-level 54 mm Plate

MaxAn Anterior Cervical Plate System Instructions for Use

3 Pages

INDICATIONS FOR USE The MaxAn Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 – T1.  MaxAn® Anterior Cervical Plate  only  Key-Code: 060549-01 http://ifu.zimmerbiomet.com/spine  Zimmer Biomet Spine, Inc. 10225 Westmoor Dr. Westminster, CO 80021 USA +1 800.447.3625 zimmerbiomet.com  Biomet Global Supply Chain Center B.V. Hazeldonk 6530 4836 LD Breda The Netherlands  CONTRAINDICATIONS 1. Spinal infection or inflammation 2. Morbid obesity 3. Mental illness, alcoholism, or drug abuse 4. Pregnancy  Commonly Used Symbols for Medical Devices  Note: Refer to the individual package label for symbols applicable to the product. SYMBOL  DEFINITION  6. Patients with inadequate tissue coverage over the operative site.  Manufacturer  7. Open wounds local to the operative area  Date of manufacture  8. Rapid joint disease, bone absorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, the amount of mechanical fixation, and/or intolerance.  Use by date  2  Do not re-use  2  Do not re-sterilize  Sterilize  IMPORTANT NOTE These implants are intended only to assist healing and are not intended to replace normal body structures. Delayed union or nonunion of bone in the presence of weight bearing or load bearing, could eventually break the implant due to metal fatigue. Therefore, it is important that immobilization of the operative site be maintained until firm bony union (confirmed by clinical and radiographic examination) is established. Factors such as the patient’s weight, activity level, and adherence to weight bearing or load bearing instructions have an effect on the load and number of cycles to which the implant is subjected. The surgeon must be thoroughly knowledgeable in the medical, surgical, mechanical and metallurgical aspects of the implants. Postoperative care is extremely important. The patient should be warned that noncompliance with postoperative instructions could lead to breakage of the implants and/or possible migration requiring revision surgery to remove the device.  Do not use if package is damaged Diameter Consult instructions for use Caution: Consult accompanying documents MR conditional Non-sterile  NON STERILE  O  5. Metal sensitivity/foreign body sensitivity  Sterilized using ethylene oxide Sterilized using irradiation Quantity per package Batch code Reference  WARNINGS 1. This device is not approved for screw attachments to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.  Authorized representative in the european community Caution: Federal (USA) law restricts this device to sale by or on the order of a physician  INSTRUCTIONS FOR USE  en  ATTENTION OPERATING SURGEON DESCRIPTION The MaxAn Anterior Cervical Plate System is a plate and screw system composed of titanium alloy (Ti-6Al-4V ELI). The system includes self-drilling bone screws, which are available in various diameters. The plates have an integral locking component that secures the bone screws into the plate. Various instruments are available to facilitate implantation of the device. MATERIALS The MaxAn Anterior Cervical Plate System’s implants are made from Ti-6Al-4V conforming to ASTM standard F-136.  2. Selection of Implants. Selection of proper size, shape and design of the implant increase the potential for success. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size and strength of implants. 3. Implant Strength and Loading. These devices are not designed to withstand the unsupported stress of full weight bearing and/or load bearing, and cannot withstand activity levels and/or loads equal to those placed on normal healthy bones. If healing is delayed or does not occur, the implant could eventually break due to metal fatigue. Loads produced by weight bearing and activity levels will dictate the longevity of the implant. 4. Corrosion. Contact of dissimilar metals (e.g., titanium and stainless steel) accelerates the corrosion process, which could enhance fatigue fracture of the implants. Therefore, only use like or compatible metals with implants that are in contact with each other.  060549-01-en Rev 08 2021-08  1
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