Endoskeleton TO Interbody Fusion Device Instructions

▪ The Endoskeleton™ TO Interbody Fusion Device should not be implanted in patients with a prior fusion at the levels to be treated.

PREOPERATIVE ▪ Only patients that meet the criteria described in the indications should be selected. ▪ Based on fatigue testing results, when using the Endoskeleton™ TO Interbody Fusion Device, the physician/

surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact performance of this system. ▪ Safety and effectiveness were not established in patients with the following conditions and/or dispositions which should be avoided: ▪ Morbid obesity. ▪ Symptomatic cardiac disease. ▪ Pregnancy. ▪ Signs of local inflammation. ▪ Fever or leukocytosis. ▪ Metal sensitivity and/or allergy to the implant materials. ▪ Medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count. ▪ Grossly distorted anatomy due to congenital abnormalities. ▪ Osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication since this condition may limit obtainable correction, amount of mechanical fixation, and/or quality of the bone graft). ▪ Long term systemic corticosteroid use. ▪ Active drug abuse. ▪ Any case requiring the mixing of metals from different components. ▪ Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition. ▪ Any patient unwilling to cooperate with the postoperative instructions. ▪ Any time implant use would interfere with anatomical structures or expected physiological performance. ▪ Other conditions may exist where safety and effectiveness were not established. ▪ Care should be used when handling and storing implants and instruments. Implants should not be scratched or otherwise damaged. Implants and instruments should be protected during storage, especially from corrosive environments. Devices should be routinely inspected. if they exhibit wear, damage, corrosion, or discoloration they should be returned to Medtronic for further evaluation. ▪ The type of construct to be assembled for the case should be determined prior to surgery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used. ▪ Unless sterile packaged, all devices should be sterilized before use. Additional sterile components should be available in case of an unexpected need. ▪ Since mechanical parts are involved, the surgeon should be familiar with the various components before use and should personally assemble the devices to verify all parts and necessary instruments are present before surgery. ▪ Patients who smoke were shown to have an increased incidence of nonunion. Therefore, these patients should be advised of this fact and warned of the potential consequences. ▪ Postoperative care is important. The patient should be instructed in the limitations of implants and should be cautioned regarding weight bearing and body stress on the appliance prior to secure bone healing.

INTRAOPERATIVE ▪ Instruction manuals should be carefully followed. ▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves may occur resulting in loss of neurological functions.

▪ Implant surfaces should not be scratched or notched since such actions may reduce the functional strength of the construct.

▪ Either autograft, cancellous and/or corticocancellous allograft, demineralized allograft with bone marrow

aspirate or a combination thereof must be placed in the area to be fused and the graft must be in contact with viable bone. ▪ Internal and external threads on instruments can be damaged by cross-threading. Inspect internal and external threads for damage prior to assembly. If threads are damaged, set the product aside and do not use. When threading components together, keep to the thread axis. Screw in the component as far as it will go and make sure the product is flush with the insertion instrument. On all threaded connections, provisionally (finger) tighten only.

POSTOPERATIVE ▪ The physician’s postoperative directions and warnings to the patient and corresponding patient compliance are extremely important.

▪ Detailed instructions on use and limitations of implants 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 implants are complications which can occur as a result of excessive or early weight bearing or excessive muscular activity. Risk of bending, loosening, or breakage of an internal fixation device during postoperative rehabilitation may be increased if the patient is active, debilitated, demented or otherwise unable to use weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position. ▪ To allow maximum chances for a successful surgical result, the patient should not be exposed to mechanical vibrations that may loosen implants. The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting, 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 on body motion. ▪ If a nonunion develops or if implants loosen, bend, and/or break, implants should be revised and/or removed immediately before serious injury occurs. Failure to immobilize a delayed or nonunion of bone will result in excessive and repeated stresses on implants. By the mechanism of fatigue, these stresses can cause eventual bending, loosening, or breakage of implants. 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. ▪ Retrieved implants should be treated in such a manner that reuse in another surgical procedure is not possible. When explanting and/or disposing of a device, be sure to avoid exposure to bodily substances such as blood, tissue, etc., as contact could lead to infection or disease. Always wear and use proper equipment, taking special care with sharp objects and needles. Follow your healthcare center’s policy regarding both the disposal of devices and any events of exposure. Physician note: although the physician is the learned intermediary between the company and the patient, the important medical information in this document should be conveyed to the patient. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

ADVERSE EVENTS Possible adverse effects may include: ▪ Bending, loosening, or fracture of implants or instruments. ▪ Loss of fixation. ▪ Sensitivity to a metallic foreign body, including possible tumor formation. ▪ Skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications. ▪ Nonunion or delayed union. ▪ Infection. ▪ Nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis, and cerebral fluid leakage. ▪ Gastrointestinal, urological, and/or reproductive system compromise including sterility, impotency, and/or loss of consortium. ▪ Pain or discomfort. ▪ Bone loss due to resorption or stress shielding, or bone fracture at, above, or below the level of surgery (fracture of the vertebra). ▪ Hemorrhage of blood vessels and/or hematomas. ▪ Malalignment of anatomical structures, including loss of proper spine curvature, correction, reduction, and/or height. ▪ Bursitis. ▪ Bone graft donor site pain. ▪ Inability to resume activities of normal daily living. ▪ Death. Note: additional surgery may be necessary to correct some of these potential adverse events.

CLEANING & STERILIZATION Refer to Reprocessing Instructions for Titan Devices 70-0015/ M333023W134 for detailed instruction, including disassembly/assembly and sterilization instructions. Endoskeleton™ TO Interbody Fusion Device implants are provided either sterile or non-sterile, see package labeling for identification. Endoskeleton™ TO Interbody Fusion Device implants and instruments provided non-sterile must be cleaned and sterilized using a validated sterilization method prior to use. Thoroughly clean instrumentation, especially long and narrow lumens and blind holes carefully. Clean instruments as soon as possible after use, and then sterilize them. Repeat cleaning if instrumentation is not visually clean. The detergent manufacturer’s instructions should be followed to achieve the correct dilution, temperature, contact time, and water quality. Hospital approved methods should be followed when handling implants or instruments contaminated with blood, tissue, and/or bodily fluid. The Endoskeleton™ TO System must be sterilized in a properly functioning, calibrated steam sterilizer. The following sterilization cycles (in accordance with ANSI/AAMI ST79 or ISO 14937 and ISO 17665-1) are recommended for use with FDA-cleared sterilization wraps: