1. Active systemic infection or infection local to operative area
2. Morbid obesity
3. A patient who in the surgeon’s opinion is not psychosocially, mentally or physically able to fully comply with the postoperative treatment regimen (e.g., mental illness, alcoholism or drug abuse)
4. Pregnancy
5. Metal sensitivity/foreign body sensitivity
6. Patients with inadequate tissue coverage over the operative site
7. Open wounds local to the operative area

1. 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. Potential risks identified with the use of this device, which may require additional surgery, include device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
2. Implant Strength and Loading. The Lineum OCT Spine System is intended to assist healing and is not intended to replace normal bony structures. Loads produced by weight bearing and activity levels will dictate the longevity of the implant. These devices are not designed to withstand the unsupported stress of full weight bearing or load bearing, and cannot withstand activity levels and/or loads equal to those placed on normal healthy bone. If healing is delayed or does not occur, the implant could eventually break due to metal fatigue. Therefore, it is important that immobilization of the operative site be maintained until firm bony union (confirmed by clinical and radiographic examination) is established. The surgeon must be thoroughly knowledgeable in the mechanical and metallurgical aspects of the Lineum OCT Spine System.
3. Postoperative care is extremely important. Detailed instructions on the use and limitations of the device should be given to the patient. The patient should be warned that noncompliance with postoperative instructions could lead to loosening or breakage of the implant and/or possible migration requiring revision surgery to remove the implant. The patient should be warned of these possibilities and instructed to limit and restrict physical activities especially lifting, twisting and any type of sport participation. Patients who smoke have been shown to have an increased incidence of nonunion. Therefore, these patients should be advised of this fact and warned of the potential consequences.
4. Selection of Implants. Selection of the proper size, shape and design of the implant increases the potential for success. While proper selection can help minimize risks, the size and shape of human bones present size limitations on the implants.
5. Metabolic bone disease such as severe osteoporosis may adversely affect adequate fixation of the implants due to the poor quality of the bone.
6. The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. They 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. All nonsterile components and instruments must be cleaned and sterilized before use.
7. Biomet spine implants should never be used with implants or instruments from another manufacturer for reasons of metallurgy, mechanics and design.
8. Corrosion. Contact of dissimilar metals accelerates the corrosion process, which could increase the possibility of fatigue fracture of the implants. Therefore, only use like or compatible metals for implants that are in contact with each other. Never use stainless steel and titanium implant components in the same construct. Cobalt Chrome Alloy rods should not be used with Stainless Steel Components. Cobalt Chrome Alloy rods are to be used ONLY with titanium implant components in the same construct.
9. The Lineum OCT Spine System has not been evaluated for safety and compatibility in the MR environment. The Lineum OCT Spine System has not been tested for heating or migration in the MR environment.

1. Do not reuse implants. While an implant may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant. Do not treat patients with implants that have been even momentarily placed in or used on a different patient. 
2. Handling of Implants. If contouring of the rod is required, avoid sharp bends and reverse bends. Avoid notching or scratching of implants, which could increase internal stresses and lead to early breakage. 
3. Implant Removal After Healing. After healing is complete, the implant is intended to 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 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. Please refer to the specific surgical technique for this device for more information. For a copy of the surgical technique, please contact your sales representative or customer service at the address provided below. Preoperative planning and patient anatomy should be considered when selecting implant diameter and length. 
6. At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves may occur resulting in a loss of neurological functions. 
7. Bone grafts must be placed in the area to be fused and the graft must contact viable bone. 
8. PRE-OP PLANNING - Use of cross sectional imaging (i.e., CT and/or MRI) for posterior cervical screw placement is recommended due to the unique risks in the cervical spine. The use of planar radiographs alone may not provide the necessary imaging to mitigate the risk of improper screw placement. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary​.

Possible adverse effects include, but are not limited to:

1. Bending, loosening or fracture of the implants or instruments;
2. Loss of fixation;
3. Sensitivity to a metallic foreign body, including possible tumor formation;
4. Skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications;
5. Nonunion or delayed union;
6. Infection;
7. Nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis, and cerebral spinal fluid leakage;
8. Pain or discomfort,
9. Bone loss due to resorption or stress shielding, or bone fracture at, above or below the level of surgery (fracture of the vertebra);
10. Hemorrhage of blood vessels and/or hematomas;
11. Malalignment of anatomical structures, including loss of proper spinal curvature, correction, reduction and/or height;
12. Bursitis
13. Inability to resume activities of normal daily living;
14. Reoperation;
15. Death.

Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminster, CO 80021 USA