INDICATIONS, SAFETY, AND WARNINGS On the CD Horizon™ Spinal System

PURPOSE

The CD HORIZON™ Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.

DESCRIPTION

INDICATIONS

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

• 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.

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

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

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.

IMPLANT SELECTION

DEVICE FIXATION

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

• 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, 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

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 2: Sterilization cycle parameters for medical facilities outside the US and its territories

¹ The 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

PRODUCT COMPLAINTS

FURTHER INFORMATION

BRIEF STATEMENT

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.