• Patented variable screw hole allows optimal placement of plate with maximized screw purchase
• Proprietary articulating plate inserter eases plate insertion through the lateral approach
• Available in eight lengths with 5.5 and 6.5mm diameter self-locking screws

Devices are supplied nonsterile. For sterilization instructions, please reference the package insert.

Indications

The LAT-FUSE Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Contraindications

Use of the LAT-FUSE Lateral Plate System is contraindicated when:

1. There is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implanted materials.
2. Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant.
3. Metastatic tumors are present in the adjacent vertebral bodies.
4. Conditions that may place excessive stresses on bone and implants, such that severe obesity or degenerative disease are relative contraindications. The decision whether to use these devices in such conditions must be made by the physician, taking into account the risks verses the benefits to the patient.

Use of these implants is relatively contraindicated in patients whose activity, mental capability, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure.

Warnings

This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The safety and effectiveness of this system has 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 (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.

One of the potential risks identified with this system is death. Other potential risks which may require additional surgery, include:

• Device component fracture
• Loss of fixation
• Non-union
• Fracture of the vertebrae
• Neurological injury, and
• Vascular or visceral injury

The components of this device are manufactured from biocompatible implant grade materials. Mixing of certain implant components with different materials is not recommended, for metallurgical, mechanical and functional reasons.

No implant and screw system can withstand the forces of sudden dynamic loads such as falls or other accidents.

Precautions

Only experienced spinal surgeons should perform the implantation of anterior lumbar spinal systems with specific training in the use of this spinal system. This is a technically demanding procedure presenting a risk of serious injury to the patient. Preoperative planning and patient anatomy should be considered when selecting screw diameter and length. While proper selection can help minimize risks, the size, shape, bone quality, stock, and differentiation of anatomical structures 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. Based on fatigue testing results, when using the LAT-FUSE Lateral Plate System, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact the performance of the system. 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 bending, loosening, or breakage. Patients should be fully informed of the risks of implant bending, loosening, or breakage.

The components of this device are manufactured from titanium alloy. Mixing of implant components with different materials is not recommended, for metallurgical, mechanical and functional reasons. Mixing metals can cause corrosion. There are many forms of corrosion 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 plates, rods, hooks, wires, etc. which come into contact with other metal objects, must be made from like or compatible metals. Plates and screws of this system should not be interchanged with components of any other system or manufacturer.

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 and internal stress patterns which may lead to early breakage.

Correct handling of the implant is extremely important. Contouring of the metal implants should only be done 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.

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 which can lead to bending, loosening, or breakage of the appliance and the operation.
• The patient’s occupation or activity. If the patient is involved in an occupation or activity which includes substantial walking, running, lifting or muscle strain, the resultant forces can cause bending, loosening, breakage 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 bending, loosening, breakage 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, orthopedic 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 pseudoarthrosis following surgical procedures where bone graft is used.
• Presence of documented infection or inflammation. Patients with infections and inflammation are more likely to encounter further complications.
• Presence of severe osteopenia and/or osteoporosis.

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.

Device presence may cause pain, discomfort, abnormal sensations, and increased risk of infection. Instruct the patient to seek medical attention if sudden changes in appearance at the surgical site are noticed or if an unexplained increase in pain is experienced.

Factors such as the patient’s weight, activity level, and adherence to weight bearing or load bearing instructions have an effect on the stresses to which the implant is subjected.

MRI Safety Information

The LAT-FUSE Lateral Plate System implants are manufactured from implant grade materials that are nonferromagnetic. The LAT-FUSE Lateral Plate System has not been tested for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the LAT-FUSE Lateral Plate System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

See product specific surgical technique manual and package insert for complete instructions and labeling limitations.