ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM Instructions for Use

POTENTIAL ADVERSE EVENTS All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of potential adverse events includes, but is not limited to: ▪ Early or late loosening of any or all of the components. ▪ Disassembly, bending, and/or breakage of any or all of the components. ▪ Foreign body (allergic) reaction to implants, debris, corrosion products, graft material, including metallosis, staining, tumor formation, and/or auto-immune disease. ▪ Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, and/or pain. ▪ Bursitis and tissue damage caused by improper positioning and placement of implants or instruments. ▪ Post-operative change in spinal curvature, loss of correction, height, and/or reduction. ▪ Infection. ▪ Dural tears. ▪ Loss of neurological function, including paralysis (complete or incomplete), dysesthesias, hyperesthesia, anesthesia, paraesthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, or tingling sensation. ▪ Neuropathy, neurological deficits (transient or permanent), bilateral paraplegia, reflex deficits, and/or arachnoiditis. ▪ Loss of bowel and/or bladder control or other types of urological system compromise. ▪ Scar formation possibly causing neurological compromise around nerves and/or pain. ▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery. ▪ Interference with roentgenographic, CT, and/or MR imaging because of the presence of the implants. ▪ Non-union (or pseudarthrosis), delayed union, and mal-union. ▪ Cessation of any potential growth of the operated portion of the spine. ▪ Loss of spinal mobility or function. ▪ Inability to perform the activities of daily living. ▪ Bone loss or decrease in bone density, possibly caused by stress shielding. ▪ Graft donor site complications including pain, fracture, or wound healing problems. ▪ Atelectasis, ileus, gastritis, herniated nucleus pulposus, and/or retropulsed graft. ▪ Hemorrhage, hematoma, seroma, embolism, edema, stroke, excessive bleeding, phlebitis, wound necrosis, wound dehiscence, or damage to blood vessels. ▪ Gastrointestinal and/or reproductive system compromise, including sterility and loss of consortium. ▪ Development of respiratory problems (e.g., pulmonary embolism, bronchitis, pneumonia, etc.). ▪ Change in mental status. ▪ Death. Note: Additional surgery may be necessary to correct some of these anticipated adverse events.

WARNINGS AND PRECAUTIONS A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results. The ATLANTIS® Anterior Cervical Plate System is only a temporary implant used for the correction and stabilization of the spine. This system is also intended to be used to augment the development of a spinal fusion by providing temporary stabilization. This device system is not intended to be the sole means of spinal support. Bone grafting must be part of the spinal fusion procedure in which the ATLANTIS® Anterior Cervical Plate System is utilized. Use of this product without a bone graft or in cases that develop into a non-union will not be successful. This spinal implant cannot withstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s) will eventually occur. Preoperative planning and operating procedures including knowledge of surgical techniques, proper reduction, and proper selection and placement of the implant are important considerations in the successful utilization of the ATLANTIS® Anterior Cervical Plate by the surgeon. Further, the proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol and/or other drug abuse patients are also not good candidates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also not good candidates for spine fusion. The implants are not prostheses. A device that has been implanted should never be reused, reprocessed or resterilized under any circumstances. Sterile packaged devices should also never be resterilized. Reuse, reprocessing, or resterilization may compromise the structural integrity of these implants and create a risk of contamination of the implants which could result in patient injury, illness, or death.

PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient. FOR US AUDIENCES ONLY

CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN. IMPLANT SELECTION The selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the procedure. Metallic surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the size and shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and postoperative management to minimize stresses on the implant, such stresses may cause metal fatigue and consequent breakage, bending or loosening of the device before the healing process is complete, which may result in further injury or the need to remove the device prematurely.

PREOPERATIVE ▪ Only patients that meet the criteria described in the indications should be selected. ▪ Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.

▪ Care should be used in the handling and storage of the implant components. The implants should not be scratched or

otherwise damaged. Implants and instruments should be protected during storage especially from corrosive environments. ▪ The type of construct to be assembled for the case should be determined prior to beginning the surgery. An adequate inventory of implants should be available at the time of surgery; normally a quantity in excess of what is expected to be used. ▪ Since mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the devices to verify all parts and necessary instruments are present before the surgery begins. The ATLANTIS® Anterior Cervical Plate System components are not to be combined with the components from another manufacturer. Different metal types should not be used together. ▪ All components and instruments should be cleaned and sterilized before use. Additional sterile components should be available in case of an unexpected need.

INTRAOPERATIVE ▪ Any instruction manuals should be carefully followed. ▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves will cause loss of neurological functions.

▪ When the configuration of the bone cannot be fitted with an available temporary internal fixation device, and contouring

is absolutely necessary, it is recommended that such contouring be gradual and great care be used to avoid notching or scratching the surface of the device(s). The components should not be repeatedly or excessively bent any more than absolutely necessary. The components should not be reverse bent at the same location. ▪ The implant surfaces should not be scratched or notched, since such actions may reduce the functional strength of the construct. ▪ Bone grafts must be placed in the area to be fused and the graft must be extended from the upper to the lower vertebrae to be fused. ▪ Bone cement should not be used since this material will make removal of the components difficult or impossible. The heat generated from the curing process may also cause neurologic damage and bone necrosis. ▪ Before closing the soft tissues, all of the screws should be seated onto the plate. Recheck the tightness of all screws after finishing to make sure that none has loosened during the tightening of the other screws. Also, secure the locking mechanism into place to cover the screw heads.

POSTOPERATIVE The physician’s postoperative directions and warnings to the patient, and the corresponding patient compliance, are extremely important. ▪ Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight-bearing is recommended or required prior to firm bony union, the patient must be warned that bending, loosening, or breakage of the components are complications which can occur as a result of excessive or early weight-bearing or excessive muscular activity. The risk of bending, loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the patient is active, or if the patient is debilitated, demented, or otherwise unable to use crutches or other such weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position. ▪ To allow the maximum chances for a successful surgical result, the patient or device should not be exposed to mechanical vibrations that may loosen the device construct. The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient should be advised not to smoke or consume alcohol during the bone graft healing process. ▪ The patient should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent physical restriction in body motion. ▪ If a non-union develops or if the components loosen, bend, and/or break, the device(s) should be revised and/or removed immediately before serious injury occurs. Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant. By the mechanism of fatigue, these stresses can cause eventual bending, loosening, or breakage of the device(s). It is important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by roentgenographic examination. The patient must be adequately warned of these hazards and closely supervised to ensure cooperation until bony union is confirmed.

▪ The ATLANTIS® Anterior Cervical Plate System implants are temporary internal fixation devices. Internal fixation

devices are designed to stabilize the operative site during the normal healing process. After the spine is fused, these devices serve no functional purpose and should be removed. In most patients, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. 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 post-operative 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. ▪ While the surgeon must make the final decision on implant removal, it is the position of the Orthopedic Surgical Manufacturers Association that whenever possible and practical for the individual patient, bone fixation devices should be removed once their service as an aid to healing is accomplished, particularly in younger and more active patients. Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure and the difficulty of removal. Implant removal should be followed by adequate postoperative management to avoid fracture. ▪ Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. As with all orthopedic implants, none of the ATLANTIS® Anterior Cervical Plate System components should ever be reused under any circumstances.

PACKAGING Devices may be supplied in a sterile or non-sterile form. Packages for each of the components should be intact upon receipt. Once the seal on the sterile package has been broken, the product should not be re-sterilized. If a loaner or consignment system is used, all sets should be carefully checked for completeness and all components should be carefully checked to ensure that there is no damage prior to use. Damaged packages or products should not be used, and should be returned to Medtronic.

CLEANING AND DECONTAMINATION Remove all packaging material prior to disassembly (if applicable), cleaning, and sterilization. All reusable instruments must be disassembled (if applicable) and thoroughly cleaned prior to sterilization or if applicable, cleaned and decontaminated before being returned to Medtronic. Always immediately clean and re-sterilize all instruments used in surgery. Cleaning instructions and associated disassembly instructions (if applicable) can be found at http://manuals.medtronic.com. Note: certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach, and/or other alkaline cleaners may damage some devices, particularly instruments. These solutions should not be used. Also, many instruments require disassembly before cleaning. All products should be treated with care. Improper use or handling may lead to damage and/or possible improper functioning of the device.

STERILIZATION Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants used in surgery must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization. Only sterile products should be placed in the operative field. Unless specified elsewhere, these products are recommended to be steam sterilized by the hospital using one of the sets of the following process parameters: Table 1: Sterilization Cycle Parameters for the United States and its Territories: METHOD CYCLE TEMPERATURE EXPOSURE TIME Steam Gravity Displacement 250°F (121°C) 30 Minutes Steam Gravity Displacement 270°F (132°C) 15 Minutes Steam Gravity Displacement 275°F (135°C) 10 Minutes Steam Dynamic-Air-Removal 270°F (132°C) 4 Minutes Steam Dynamic-Air-Removal 275°F (135°C) 3 Minutes

MINIMUM DRY TIME1 30 Minutes 30 Minutes 30 Minutes 30 Minutes 16 Minutes

*For Medical Facilities Located Outside the United States and its Territories. Some non-U.S. health care authorities recommend sterilization according to these parameters so as to minimize the potential risk of transmission of CreutzfeldtJakob disease, especially of surgical instruments that could come into contact with the central nervous system. Table 2: Sterilization Cycle Parameters for Medical Facilities Outside the United States and Its Territories: METHOD CYCLE TEMPERATURE EXPOSURE TIME MINIMUM DRY TIME1 Steam Gravity Displacement 273°F (134°C) 20 Minutes 30 Minutes Steam Dynamic-Air-Removal 273°F (134°C) 4 Minutes 30 Minutes Steam Dynamic-Air-Removal 273°F (134°C) 20 Minutes 30 Minutes 1The minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient

atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations. NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization process (e.g. temperatures, times) used for their equipment.

PRODUCT COMPLAINTS Any health care professional (e.g., customer or user of this system of products) who has any complaints or who has experienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness, and/or performance, should notify the distributor or Medtronic. Further, if any of the implanted spinal system component(s) ever “malfunctions” (i.e., does not meet any of its performance specifications or otherwise does not perform as intended), or is suspected of doing so, the distributor should be notified immediately. If any Medtronic product ever malfunctions and may have caused or contributed to the death or serious injury of a patient, the distributor should be notified immediately by telephone, fax, or written correspondence. When filing a complaint, provide the component(s) name and number, lot number(s), your name and address, the nature of the complaint, and notification of whether or not a written report from the distributor is requested.

MRI INFORMATION The ATLANTIS® Anterior Cervical Plate System has not been evaluated for safety, heating, migration, or compatibility in the magnetic resonance environment.

FURTHER INFORMATION Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If further information is needed or required, contact Medtronic. ©2014 Medtronic Sofamor Danek USA, Inc. All rights reserved.