Warnings

Following are specific warnings, precautions, and adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal fixation devices.

General surgical risks should be explained to the patient prior to surgery.

• IN THE U.S.A., THIS PRODUCT HAS LABELING LIMITATIONS.
• 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 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 these devices for any other conditions is unknown.
• BENEFIT OF SPINAL FUSIONS UTILIZING ANY PEDICLE SCREW FIXATION SYSTEM HAS NOT BEEN ADEQUATELY ESTABLISHED IN PATIENTS WITH STABLE SPINES. Potential risks identified with the use of this device system, which may require additional surgery, include:
  • Device component fracture.
  • Loss of fixation.
  • Non-union.
  • Fracture of the vertebra.
  • Neurological injury.
  • Vascular or visceral injury.
• CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape and design of the implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of implants. Metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing.
• IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NON-UNION. Internal fixation appliances are load sharing devices which are used to obtain an alignment until normal healing occurs. If healing is delayed or does not occur, the implant may eventually break due to metal fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending  of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of  implant failure.
• MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion 6. damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerate the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, wires, etc. which come into contact with other metal objects, must be made from like or compatible metals.
• PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be of extreme importance to the eventual success of the procedure:
  • The patient’s weight. An overweight or obese patient can produce loads on the device that can lead to failure of the appliance and the operation.
  • The patient’s occupation or activity. If the patient is involved in an occupation or activity that includes substantial walking, running, lifting or muscle strain, the resultant forces can cause failure of the device.
  • A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications.
  • Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary relief.
  • Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation.
  • Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where autograft or allograft is used.
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Precautions

• THE IMPLANTATION OF PEDICLE SCREW SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED 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.
• SURGEONS SHOULD HAVE KNOWLEDGE OF HOW TO TARGET PEDICLE SCREWS USING FLUOROSCOPY AND K-WIRE WHEN UTILIZING A MINIOPEN OR PERCUTANEOUS SURGICAL TECHNIQUE.
• SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted metal implant should never be re-implanted. Even though the device appears undamaged, it may have small defects andinternal stress patterns that may lead to early breakage.
• CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of the metal implants should only be performed with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Bending of screws will significantly decrease fatigue life and may cause failure.
• REMOVAL OF THE IMPLANT AFTER HEALING. Metallic implants can loosen, fracture, corrode, migrate, possibly increase the risk of infection, cause pain, or stress shield bone even after healing, particularly in young, active patients. The surgeon should carefully weigh the risk versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risk involved with a second surgery.
• ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient’s ability and willingness to follow instructions are one of the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant and that physical activity and full weight bearing have been implicated in bending or fracture. The patient should understand that a metallic implant is not as strong as normal, healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing. An active, debilitated, or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation.
• All implants and some instruments are intended for single-use only; refer to the product label to determine if the instrument is single use only. Single use devices should not be re-used. Possible risks associated with re-use of single-use devices include:
  • Mechanical malfunction
  • Transmission of infectious agents

Complications and adverse reactions have been reported with the use of similar spinal instrumentation systems. These adverse effects, including the possibility of death, should be discussed with the patient prior to surgery.

• Non-union, delayed union.
• Bending or fracture of implant. Fraying, kinking, loosening, bending or breaking of any or all of the cable implant components.
• Loosening of the implant.
• Metal sensitivity, or allergic reaction to a foreign body. 
• Infection.
• Decrease in bone density due to stress shielding.
• Pain, discomfort, or abnormal sensations due to the presence of the device 
• Loss of proper spinal curvature, correction height and/or reduction.
• Cable cutting through soft osteoporotic, osteogenic or cancellous bone.
• Vascular and/or nerve damage due to surgical trauma or presence of the device. 
• Neurological difficulties including bowel and/or bladder dysfunction, impotence, retrograde ejaculation, and paraesthesia.
• Bursitis. 
• Dural leak. 
• Paralysis. 
• Death.
• Erosion of blood vessels due to the proximity of the device, leading to hemorrhage and/or death.