CD HORIZON Spinal System Important Information

spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON™ Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD HORIZON™ LEGACY™ 3.5mm rods and the CD HORIZON™ Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CD HORIZON™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor. In order to achieve additional levels of fixation, the CD HORIZON™ Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

CONTRAINDICATIONS Contraindications include: ▪ 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. ▪ The CD HORIZON™ SPIRE™ Plate and the CD HORIZON™ PEEK Rods are specifically contraindicated for use in pediatric patients. ▪ 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: ▪ Early or late loosening of any or all of the components. ▪ Disassembly, bending, or breakage of any or all of the components. ▪ Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, or general corrosion) including metallosis, staining, tumor formation, 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, 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, or reduction. ▪ Infection. ▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.

▪ Loss of neurological function (e.g. sensory or motor) including paralysis (complete or incomplete),

dysesthesias, hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, or the development or continuation of pain, numbness, neuroma, spasms, sensory loss, tingling sensation, or visual deficits. ▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits, irritation, arachnoiditis, 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 or pain. ▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, or vertebral body) or bone graft or bone graft harvest site at, above, 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. ▪ Cessation of any potential growth of the operated portion of the spine. ▪ 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.

ADDITIONAL POTENTIAL ADVERSE EVENTS FOR PEDIATRIC PATIENTS ▪ Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions and/or distorted anatomy).

▪ Pedicle screw malpositioning, with or without neurological or vascular injury. ▪ Proximal or distal junctional kyphosis. ▪ Pancreatitis. 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 degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of this device for any other conditions are unknown. The implants are not prostheses. In the absence of fusion, the instrumentation and/or one or more of its components can be expected to pull out, bend, or fracture as a result of exposure to every day mechanical stresses. A device that has been implanted should never be reprocessed or reused under any circumstances. Sterile packaged devices should also never be resterilized. Reprocessing or reuse 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.

ADDITIONAL WARNINGS FOR PEDIATRIC PATIENTS Warning: the safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive fusion is being performed at all instrumented levels. The use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature and skeletally immature. Pediatric patients may have smaller spinal structures (pedicle diameter or length) that may preclude the use of pedicle screws or increase the risk of pedicle screw malpositioning and neurological or vascular injury. Patients not skeletally mature that undergo spinal fusion procedures may have reduced longitudinal spinal growth, or may be at risk for rotational spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine. Other adverse events related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in pediatric patients. Pediatric patients may be at increased risk for device-related injury because of their smaller stature.

ADDITIONAL WARNING FOR THE CD HORIZON™ SPIRE™ SPINOUS PROCESS PLATE Consider the extent of decompression, as well as the amount of intact bone remaining on the spinous processes, when using the CD HORIZON™ SPIRE™ Plate as the sole supplemental fixation for an interbody fusion procedure.

PRECAUTIONS 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. 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, 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.

ADDITIONAL PRECAUTIONS FOR PEDIATRIC PATIENTS The implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system in pediatric patients because this is a technically demanding procedure presenting a risk of serious injury to the patient. 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 in pediatric patients. The selection of the proper size, shape, and design of the implant for each patient is crucial to the safe use of this device in pediatric patients. 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.

DEVICE FIXATION In cases where a percutaneous posterior approach is used, refer to the CD HORIZON™ SEXTANT™ surgical technique. CD HORIZON™ Spinal System instrumentation contains rods and implants of various diameters, which are intended to be used with device specific instruments. For self breaking plugs, always hold the assembly with the Counter Torque device. Tighten and break-off the head of the plug to leave the assembly at optimum fixation security. After the upper part of the self-breaking plug has been sheared off, further re-tightening is not necessary and not recommended. The head part should not remain in the patient. After the upper part of the self breaking plug has been sheared off, re-adjustment is not possible unless the plug is removed and replaced with a new one. When using DTT Transverse Links, the M6 plug should be tightened between 8 and 9 Nm. (70 to 80 inch-lbs). CD HORIZON™ PEEK Rods are not to be used with CROSSLINK™ Plates or in pediatric patients.

PREOPERATIVE ▪ Only patients that meet the criteria described in the indications should be selected. ▪ Patient conditions and 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 all parts and necessary instruments are present before surgery. The CD HORIZON™ Spinal System components (described in the DESCRIPTION section) are not to be combined with the components from another manufacturer. ▪ Unless sterile packaged, all devices should be 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 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. ▪ Utilize an imaging system to facilitate surgery. ▪ To insert a screw properly, a guide wire should first be used, followed by a sharp tap. Caution: be careful the guide-wire, if used, is not inserted too deep, becomes bent, and/or breaks. Ensure the guide-wire does not advance during tapping or screw insertion. Remove the guide-wire and make sure it is intact. Failure to do so may cause the guide wire or part of it to advance through the bone and into a location that may cause damage to underlying structures. ▪ Caution: do not overtap or use a screw/bolt that is either too long or too large. Overtapping, using an incorrectly sized screw/bolt, or accidentally advancing the guidewire during tap or screw/bolt insertion may cause nerve damage, hemorrhage, or the other possible adverse events listed elsewhere in this package insert. If screws/bolts are being inserted into spinal pedicles, use as large a screw/bolt diameter as will fit into each pedicle. ▪ 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. ▪ To ensure maximum stability, two or more CROSSLINK™ plates or DTT Transverse Links on two bilaterally placed, continuous rods should be used whenever possible. ▪ Bone cement should not be used because the safety and effectiveness of bone cement has not been determined for spinal uses, and 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, provisionally tighten (finger tighten) all of the nuts or screws, especially screws or nuts that have a break-off feature. Once this is completed, go back and firmly tighten all of the screws and nuts. Recheck the tightness of all nuts or screws after finishing to make sure none loosened during the tightening of the other nuts or 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 weightbearing 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, utilize nicotine products, or 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, or break, the device(s) should be revised 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 CD HORIZON™ Spinal 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 may 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 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 CD HORIZON™ Spinal System components should never 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 there is no damage prior to use. Damaged packages or products should not be used, and should be returned to Medtronic.

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 US and its territories Method Cycle Temperature Exposure time 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

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 US and its territories, some non-US health care authorities recommend sterilization according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob 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 US and its territories Method Cycle Temperature Exposure time Minimum dry time1 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. Only sterile products should be placed in the operative field. The general instruments used with this device are provided non-sterile. Refer to the instrument package insert for sterilization parameters and requirements. No implant should be re-used once it comes into contact with human tissue or body fluid. Always immediately clean and re-sterilize instruments that have been used in surgery. This process must be performed before handling or (if applicable) returning to Medtronic.

MRI INFORMATION The CD HORIZON™ Spinal System has not been evaluated for safety, heating, migration, or compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the CD HORIZON™ Spinal System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

PRODUCT COMPLAINTS For product problems, contact Medtronic.