MIS Fusion

Aspen® MIS FUSION SYSTEM

Important Safety Information

Purpose
The Biomet Spine® Spinous Process Fusion Plate (also known as Aspen® MIS Fusion System) is a spinous process fixation device intended to provide temporary fixation of spinal segments in the thoracic, lumbar, and sacral spine while awaiting bony fusion to take place. As with all orthopedic surgical procedures, detailed preoperative planning is essential. Preoperative diagnostic evaluation followed by carefully executed surgical technique is required. Postoperative care, individualized to suit the particular injury/disease requirements, is essential for optimum outcome. The surgeon must be fully aware of the risks and complications inherent to this type of surgery. Only those individuals with specialized training and experience in spinal surgery should attempt use of the implants.

Device Description
The Aspen system is a posterior attachment spinal fixation system composed of spinous process plates, dedicated surgical instruments, and sterilization cases. The components are used to build a construct to provide stabilization of spinal segments in the thoracic, lumbar and sacral spine to support fusion. The Aspen device is part of the Biomet Spine Spinal Fixation System, which offers the surgeon a variety of implant components from which to assemble a suitable construct according to each individual patient's needs and requirements. It is essential to use the Biomet Spine implants with their specifically designed instruments.

Materials
The Aspen implants are made of titanium alloy, Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3 standards. The Biomet Spine Spinal Fixation System also includes other implants made from commercially pure titanium per ASTM F67 and from cobalt chrome alloy per ASTM F1537. Titanium and cobalt chrome implant components may be used together within the same construct. Titanium and cobalt chrome implants should never be used with stainless steel implants.

Indications for Use
The Aspen system is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.

The Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1- S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, 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); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Aspen 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 Aspen device is intended for use with bone graft material, not intended for stand-alone use.

Contraindications
Contraindications may be relative or absolute. The choice of a particular device must be carefully weighed against the patient's overall evaluation. Circumstances listed below may reduce the chance of a successful outcome. Contraindications include, but are not limited to:

  • An allergy to titanium or cobalt chrome alloys, or foreign body sensitivity. Where material sensitivity is suspected, appropriate tests must be made prior to implantation.
  • Known or suspected infection/immune system incompetence. Acute or chronic infectious diseases of any etiology or localization.
  • Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, active infection at the site or certain metabolic disorders affecting osteogenesis.
  • Morbid Obesity. An overweight or obese patient can produce loads on the spinal system, which can lead to failure of the fixation of the device or failure of the device itself.
  • Any neuromuscular deficit which places an unusually heavy load on the device during the healing period.
  • Open Wounds.
  • Pregnancy.
  • Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of the white blood count (WBC), or a marked left shift in the WBC differential count.
  • Any case requiring the mixing of components from other manufacturers' systems.
  • Any case requiring the mixture of stainless steel with titanium, or stainless steel with cobalt chrome implant components.
  • Fever or leukocytosis.
  • Signs of local infection or inflammation.
  • Previous history of infection.
  • Alcoholism or heavy smoking.
  • Senility, mental illness or substance abuse, of a severity that the patient may ignore certain necessary limitations and precautions in the use of the implant, leading to failure or other complications.
  • Any patient unwilling to follow postoperative instructions.
  • Inadequate tissue coverage over the operative site.
  • The Aspen device is also contraindicated for incompetent or missing posterior arch (e.g., laminectomy, pars defect, severe osteoporosis).

Possible Complications
Possible complications specific to the device may include:

  • Early or late implant bending, breakage, failure, loosening or movement/migration
  • Bone and/or spinous process fracture
  • Allergic reaction to implant material

Other general complications associated with any spinal surgical procedure may include: non-union or delayed union, pseudarthrosis; pain; second surgery; bleeding; infection, early and late; tissue or nerve damage, including dural tears or other neurological problems; incisional complications; scar formation; damage to blood vessels and cardiovascular system compromise; changes in mental status; damage to internal organs and connective tissue; complications due to the use of bone grafting, including graft donor site complications; respiratory problems; reactions to anesthesia and/or death.

Warnings
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery, where many extenuating circumstances may compromise the results

Precautions

  • The Aspen implants are for single use only. Never reuse any implant even if it appears unmarked or undamaged. Reuse of the implant components may result in reduced mechanical performance, malfunction, or failure of the device. Any implant implanted and then removed must be discarded. Use only new implants for each case.
  • The implantation of spinal fixation systems must only be performed by experienced spinal surgeons with specific training in the use of this system due to the technically demanding procedure presenting a risk of serious injury to the patient.
  • Based on the fatigue testing results, the physician/surgeon must consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact on the performance of the system.
  • Preoperatively: The surgeon must be fully conversant with all aspects of the surgical technique and know the indications and contra-indications of this type of implant. The surgeon must have acquainted himself before the operation with the specific technique for insertion of the product, which is available from the manufacturer. As part of the preoperative examination, the surgeon must check that no biological, biomechanical or other factors will affect the correct conduct of the operation and the postoperative period. An appropriate range of implant sizes must be available at the time of the operation.
  • Intraoperatively: The correct selection of the type and size of implant appropriate to the patient and the positioning of the implant are extremely important.
  • Postoperatively: Patients must be informed of the precautions to be taken in their everyday life to guarantee a maximum implant service life. It is recommended that regular postoperative follow-up is undertaken to detect early signs of failure of the implants and to consider the action to be taken. Deterioration of the device after bone consolidation cannot be considered to constitute a dysfunction or deterioration in the characteristics of the implants. The implant can be removed after bony healing.
  • The Aspen device has not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. The Aspen device has not been tested for heating or migration in the MR environment.
  • Federal law (USA) restricts this device to sale by or on the order of a physician.