Products & Implants

Products & Implants


BacFuse® Spinous Process Plate System

BacFuse<sup>®</sup> Spinous Process Plate System Plate

The BacFuse® Spinous Process Plate System, part of the Quantum® MIS Cannulated System, allows for supplemental interspinous fixation of the thoracolumbar spine. Promoting a minimally invasive technique, the BacFuse System includes spinous process plates in a range of sizes, set screws, and surgical instrumentation.

Regulatory approvals vary by country. Therefore, we kindly ask you to contact the distributor in your region regarding availability of specific products, implants and / or instrumentation in your region.

BacFuse<sup>®</sup> Spinous Process Plate System Plate


  • Spinous Process Plates

    • Minimally invasive
    • Multiple size options
    • Ti-6Al-4V
  • Implants are supplied sterile. Instruments are supplied nonsterile. For sterilization instructions, please reference the package insert.

  • Indications

    The BacFuse® Device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The BacFuse Device is intended for use with bone graft material (i.e. allograft or autograft), and is not intended for stand-alone use.

    Warnings

    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 and lumbar 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; vascular or visceral injury.

    Warnings specific to the use of the BacFuse Device: Do not remove excessive amounts of bone, particularly from the base of the spinous processes and midline lamina. Weakening the posterior arch by aggressive bone removal may increase the risk of intraoperative or postoperative fracture of the adjoining spinous processes or posterior arch. When using the BacFuse Device, excessive distraction may result in damage to the spinous process. A possible complication specific to the device may include bone fracture including spinous process fracture.

    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.

    The BacFuse Device has not been evaluated for safety and compatibility in the Magnetic Resonance (MR) environment. The BacFuse Device has not been tested for heating or migration in the MR environment.

    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. Preoperative planning and patient anatomy should be considered when selecting pedicle screw diameter and length. 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 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, accelerates 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.

    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.

    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 about the risks and benefits of the surgery and the device. Postoperative care and the patient’s ability and willingness to follow instructions are one of the most important aspects of successful bone healing.

    It is extremely important that the physician provides clear directions and warnings and obtains the utmost compliance from the patient postoperatively:

    • Partial- or non-weight bearing may be recommended or required to achieve firm bone union.
    • Warn patient against sudden changes in position, strenuous activity, falls, smoking, consuming alcohol or other drugs not prescribed by the physician, steroids, non-steroidal anti-inflammatory agents, aspirin, and mechanical vibrations or shocks that may loosen the devices.
    • If appropriate, restrict patient’s mobility to allow bony union.
    • 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.

    The patient must be made aware of the limitations of the implant. Internal fixation devices are temporary devices that cannot support the patient’s weight or movement beyond the time typically necessary for bone healing or fusion. Physical activity and full weight bearing have been implicated in bending or fracture. The patient should understand that an 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, including falls or other high energy events such as auto accidents. If partial weight-bearing is recommended or required prior to firm bony union, the patient must be advised that bending, loosening and/or breakage of the device(s) are complications which may occur as a result of these excessive or early weight-bearing or muscular activity. An active, debilitated, or demented patient who cannot properly use weight supporting devices may be particularly at risk during postoperative rehabilitation. The patient should be advised to inquire if any questions exist regarding the appropriate activities or environments during the healing process.

    Contraindications

    Certain degenerative diseases or underlying physiological conditions such as diabetes or rheumatoid arthritis may alter the healing process, thereby increasing the risk of implant breakage.

    Mental or physical impairment which compromises or prevents a patient’s ability to comply with necessary limitations or precautions may place that patient at a particular risk during postoperative rehabilitation.

    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.

    The BacFuse Device is also contraindicated for:

    • Incompetent or missing posterior arch (e.g., laminectomy, pars defect, severe osteoporosis).

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