VERTEX Reconstruction System Instructions for Use

CONTRAINDICATIONS Contraindications include, but are not limited to: ▪ Active infectious process or significant risk of infection (immunocompromise). ▪ Signs of local inflammation. ▪ Fever or leukocytosis. ▪ Morbid obesity. ▪ Pregnancy. ▪ Mental illness. ▪ Grossly distorted anatomy caused by congenital abnormalities. ▪ Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count. ▪ Suspected or documented metal allergy or intolerance. ▪ Any case not needing a bone graft and fusion. ▪ Any case where the implant components selected for use would be too large or too small to achieve a successful result. ▪ Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. ▪ Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. ▪ Any patient unwilling to follow postoperative instructions. ▪ Any case not described in the indications. NOTA BENE: Although not absolute contraindications, conditions to be considered as potential factors for not using this device include: ▪ Severe bone resorption. ▪ Osteomalacia. ▪ Severe osteoporosis.

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 (from crevice, fretting, and/or general corrosion), including metallosis, staining, tumor formation, and/or autoimmune disease. ▪ Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, fibrosis, necrosis, and/or pain. ▪ Bursitis. ▪ Tissue or nerve 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, pseudomeningocele, fistula, persistent CSF leakage, meningitis. ▪ Loss of neurological function (e.g., sensory and/or motor), including paralysis (complete or incomplete), dysesthesias, hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, spasms, sensory loss, tingling sensation, and/or visual deficits. ▪ Neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits, irritation, arachnoiditis, and/or muscle loss. ▪ Urinary retention or loss of bladder control or other types of urological system compromise. ▪ Scar formation possibly causing neurological compromise or compression around nerves and/or pain. ▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and/or vertebral body), and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery. ▪ Retropulsed graft. ▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery. ▪ Non-union (or pseudarthrosis), delayed union, or mal-union. ▪ Loss of or increase in spinal mobility or function. ▪ Inability to perform the activities of daily living. ▪ Bone loss or decrease in bone density, possibly caused by stresses shielding. ▪ Graft donor site complications including pain, fracture, or wound healing problems. ▪ Ileus, gastritis, bowel obstruction or loss of bowel control or other types of gastrointestinal system compromise. ▪ Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, phlebitis, wound necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise. ▪ Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction. ▪ Development of respiratory problems (e.g., pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.). ▪ Change in mental status. ▪ Death. Note: Additional surgery may be necessary to correct some of these potential 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. This device system is not intended to be the sole means of spinal support. Use of this product without a bone graft or in cases that develop into a non-union will not be successful. No spinal implant can 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 and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the successful utilization of the system 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 abuse patients are also poor candidates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also poor candidates for spine fusion. Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. This system was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, 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. Other preoperative, intraoperative, and postoperative warnings and precautions are as follows:

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 pre-dispositions 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. ▪ 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 that all parts and necessary instruments are present before the surgery begins. The VERTEX® Reconstruction System components (described in the DESCRIPTION section) are not to be combined with the components from another manufacturer. Different metal types should never 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 ▪ Extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss of neurological functions.

▪ Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.

▪ The rods should not be repeatedly or excessively bent. The rods should not be reverse bent in the same location. Use

great care to ensure that the implant surfaces are not scratched or notched, since such actions may reduce the functional strength of the construct. If the rods are cut to length, they should be cut in such a way as to create a flat, non-sharp surface perpendicular to the midline of the rod. Cut the rods outside the operative field. Whenever possible, use pre-cut rods of the length needed. ▪ Whenever possible or necessary, an imaging system should be utilized to facilitate surgery.

▪ To insert a screw properly, drill a pilot hole corresponding to selected screw size and prepare screw site with a sharp tap.

▪ Caution: Do not overtap or use a screw that is either too long or too large. Overtapping or using an incorrectly sized

screw may cause nerve damage, hemorrhage, or the other possible adverse events listed elsewhere in this package insert. ▪ Bone graft must be placed in the area to be fused and graft material must extend from the upper to the lower vertebrae being fused. ▪ Before closing the soft tissues, all of the screws or set screws should be tightened firmly. Recheck the tightness of all screws or set screws after finishing to make sure that none loosened during the tightening of the other screws or set screws. Failure to do so may cause loosening of the other components.

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, and/or breakage of the device(s) are complications which may occur as a result of excessive or early weight-bearing or 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 or demented. 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 devices should not be exposed to mechanical vibrations or shock 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 tobacco or utilize nicotine products, or to consume alcohol or non-steroidals or anti-inflammatory medications such as aspirin during the bone graft healing process. ▪ The patient should be advised of their inability to bend or rotate at the point of spinal fusion and taught to compensate for this permanent physical restriction in body motion. ▪ 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 the 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. If a state of non-union persists or if the components loosen, bend, and/or break, the device(s) should be revised and/or removed immediately before serious injury occurs. The patient must be adequately warned of these hazards and closely supervised to ensure cooperation until bony union is confirmed. ▪ As a precaution, before patients with implants receive any subsequent surgery (such as dental procedures), prophylactic antibiotics may be considered, especially for high-risk patients. ▪ The VERTEX® Reconstruction 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. While the final decision on implant removal is, of course, up to the surgeon and patient, 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 postoperative trauma; (4) Bending, loosening, and 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; (7) Bone loss due to stress shielding; and (8) Potential unknown and/or unexpected long term effects such as carcinogenesis. Implant removal should be followed by adequate postoperative management to avoid fracture, re-fracture, or other complications. ▪ Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. As with all orthopedic implants, the VERTEX® Reconstruction System components should never be reused under any circumstances.

PACKAGING Packages for each of the components should be intact upon receipt. If a loaner or consignment system is used, all sets should be carefully checked for completeness and all components including instruments 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 Unless just removed from an unopened sterile Medtronic package, all instruments and implants must be unpackaged, disassembled (if applicable), and cleaned before sterilization, before introduction into a sterile surgical field, or if applicable, before returning the product to Medtronic. Remove all packaging materials prior to disassembly (if applicable) and cleaning. Cleaning instructions and associated disassembly instructions (if applicable) can be found at www.medtronic.com/manuals Note: certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or other alkaline cleaners may damage some devices, particularly instruments (see “Medtronic Reusable Instruments” Instructions for Use – part number 0380035). 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 process parameters in Table 1: 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

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. It is the end user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes) that have been cleared by the Food and Drug Administration (FDA)for the selected sterilization cycle specifications (time and temperature). The sterilization cycles listed in Table 2 are not considered by the FDA to be standard sterilization cycles. *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.

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.

MAGNETIC RESONANCE SAFETY The VERTEX® Reconstruction 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. ©2015 Medtronic Sofamor Danek USA, Inc. All rights reserved.