MaxAn Anterior Cervical Plate System Instructions for Use

PRECAUTIONS 1. Do Not Reuse. Do not reuse implants/devices. While an implant/device may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant/device. Do not treat patients with implants/ devices that have been even momentarily placed in a different patient 2. Handling of Implants. Titanium implants are to be handled with care. If contouring of the plate is required, avoid sharp bends and reverse or repetitive bends. Avoid notching or scratching of the device, which could produce internal stresses and lead to early breakage. Avoid bending across the screw holes. 3. Implant Removal After Healing. After healing is complete, the implant may be removed since it is no longer necessary. Implants that are not removed may result in complications such as implant loosening, fracture, corrosion, migration, pain or stress shielding of bone, particularly in young, active patients. Implant removal should be followed by adequate postoperative management. 4. Adequate Patient Instructions. A patient must be instructed on the limitations of the metallic implant, and should be cautioned regarding physical activity and weight bearing or load bearing prior to complete healing. 5. Surgical Techniques. The device is recommended for use by surgeons thoroughly familiar with the relative current literature, surgical techniques, implantation technique for this device, and postoperative care of the patient. Please refer to the specific surgical technique for this device for more information. 6. The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. The device must be handled and stored carefully, protected from damage, including from corrosive environments. They should be carefully unpacked and inspected for damage prior to use. 7. All instruments must be cleaned and sterilized prior to surgery. 8. Zimmer Biomet Spine implants should not be used with implants or instruments from another manufacturer for reasons of metallurgy, mechanics and design. 9. Based on fatigue testing results, when using the MaxAn Anterior Cervical Plate System, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact the performance of this system. MRI SAFETY INFORMATION MR Conditional Non-clinical testing demonstrated that the MaxAn Anterior Cervical Plate is MR Conditional. A patient with this device can be scanned safely in an MR system immediately after placement under the following conditions: • Static magnetic field of 1.5-Tesla and 3-Tesla only • Maximum spatial gradient magnetic field of 3000 Gauss/cm (30 T/m) or less • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning in the Normal Operating Mode of operation for the MR system • Under the scan conditions defined, the implants are expected to produce a maximum temperature rise of 2.7˚C after 15-minutes of continuous scanning. • When other methods of supplemental fixation are used, also follow the MR conditional labeling for the additional components.

Artifact Information MR image quality may be compromised if the area of interest is the same or relatively close to the position of the device, and it may be necessary to optimize the MR imaging parameters. In non-clinical testing, the shape of the expected artifact follows the approximate contour of MaxAn Anterior Cervical Plate and extends radially up to 26 mm from the implant when imaged using a gradient echo pulse sequence and a 3-Tesla MR system. POTENTIAL ADVERSE EFFECTS 1. Nonunion pseudarthrosis or delayed union 2. Bending, fracture, loosening or migration of the implant 3. Metal sensitivity or foreign body reaction 4. Decrease in bone density due to stress shielding 5. Pain, discomfort, or abnormal sensations due to presence of the implant 6. Nerve, soft tissue, or blood vessel damage due to surgical trauma 7. Fracture of bony structures 8. Spinal cord impingement 9. Dural Leak 10. Bursitis 11. Necrosis of the bone 12. Dysphagia/hoarseness 13. Hemorrhage 14. Infection 15. Death CLEANING INSTRUCTIONS 1. All Instrument components should be disassembled and rinsed with tap water. 2. Prepare solution of enzymatic surgical detergent and tap water by adding 2 oz. Of Enzol (Enzymatic Detergent, Johnson & Johnson) to 1 gallon of warm tap water (72ºF/22ºC to 109ºF/43ºC). Instrument components should be immersed in solution for 5 minutes. 3. Scrub components with soft brushes and rinse with a brisk stream of tap water (72ºF/22ºC to 109ºF/43ºC) until the instruments are visually clean. 4. Using an ultrasonic cleaner, sonicate all components in the same enzymatic solution (see step # 2) for 10 minutes. 5. Manually clean all components with soft brushes and repeat step # 3 until visually clean. This step should be repeated until the instruments are visually clean. 6. Dry components with a soft gauze cloth. 7. Inspect cleaned instrument for loose screws and pins, clamp alignment, cracks and other irregularities. 8. Lubricate instruments to protect instruments during sterilization and storage. This should be done with a water soluble, preserved lubricant after each cleaning. The lubricant should contain a chemical preservative to prevent bacterial growth and be made with distilled water. Excess lubricant should be wiped off prior to storage and sterilization. CARE AND HANDLING • All torque wrenches should be re- calibrated every 6 months. • Please refer to ASTM standard F1744-96, “Standard Guide for Care and Handling of Stainless Steel Surgical Instruments” for additional information. • Prior to use, instruments should be visually inspected and function should be tested to assure instruments are functioning properly. If instruments are discolored, have loose screws/pins, are out of alignment, are cracked or have other irregularities, Do Not Use. 060549-01-en Rev 08 2021-08

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STERILIZATION Unless supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use. Product provided sterile is sterilized by exposure to a minimum dose of 2.5 Megarads (25kGy) gamma radiation. Where specified, do not use implants after expiration date. These guidelines also apply to devices provided sterile where the integrity of the packaging has been compromised and re-sterilization is required prior to initial use. For product supplied non-sterile, all packaging materials must be removed prior to sterilization. The following steam sterilization parameters are recommended for both instruments and implants: Sterilization Parameters: Cycle: Pre-vacuum Steam Temperature: 270°F/132°C Time: 4 minutes Drying Time: 30 minutes Note: Allow for cooling FDA cleared sterilization wraps should be used to maintain sterility after processing. Sterilization Parameters for Use Outside of the US: Cycle: Pre-vacuum Steam Temperature: 275°F/135°C Time: 3 minutes Drying Time: 30 minutes Note: Allow for cooling Zimmer Biomet does not recommend stacking of trays during the sterilization process. Individuals or hospitals not using the recommended method, temperature, and time are advised to validate any alternative methods or cycles using an approved method or standard. Additional information about instrumentation (including assembly/ disassembly) may be found in the system surgical technique, reference guide and/or associated package inserts. The surgical technique can be obtained by contacting Zimmer Biomet’s Customer Service Department at the contact information provided below. CAUTION Federal (USA) law restricts these devices to sale by or on the order of a licensed physician. INFORMATION For further information please contact the Customer Service Department at: Zimmer Biomet Spine, Inc. 10225 Westmoor Dr. Westminster, CO 80021 USA +1 800.447.3625 zimmerbiomet.com

© 2021 Zimmer Biomet Spine, Inc. All rights reserved. All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet Spine, Inc. or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet Spine, Inc.

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