Medtronic has announced that the US Food and Drug Administration (FDA) has classified its voluntary recall action of the Intrepid Intervertebral Body Fusion Device as a Class II recall.
Medtronic initiated a voluntary recall of the product on February 6, 2009, and communicated the risk to physicians and hospitals. As of the date of this news release, all unused product has been retrieved and Medtronic has received confirmation of notification from all affected physicians and hospitals.
The Intrepid Intervertebral Body Fusion Device is intended to provide stabilisation of the vertebral bodies and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. There were approximately 650 surgeries performed using this device for which Medtronic has received 12 complaints.
The most notable of these were:
• Three reports where the device was used in patients with poor bone quality and/or gross translational instability, leading to the need for revision surgery. An adverse event associated with one of these revision surgeries was a patient death;
• Four reports of difficulty in attaching the implant cover plate; and
• One case of cover plate detachment.
The device was recalled because, upon review of the clinical experience, Medtronic had determined that there was a need to revise the labeling and modify the device design. Medtronic will be updating the labeling to reinforce that:
• Patient selection relative to both bone quality and stability is an important consideration for the proper application of this device;
• The Intrepid Intervertebral Body Fusion device requires the use of either three screws or supplemental fixation; and
• The integral cover plate must be used to reduce the potential for screw back out.
In addition, due to problems associated with cover plate attachment difficulties cited above, Medtronic has developed a new design intended to improve the ergonomics of cover plate attachment. The 510(k) submission for those modifications is currently under FDA review.
Medical assessment indicates that use of the device without adherence to the labeling criteria listed above or without a cover plate creates a risk that the implant could become unstable which could, in turn, possibly lead to the need for revision surgery. Given the close proximity of major blood vessels in the lumbar spine region, such revision surgery has the potential for serious complications.
The FDA’s classification of the voluntary recall does not alter Medtronic’s patient management recommendations as provided in the April 30, 2009 letter to physicians and risk managers:
• For implanted patients where patient bone quality or stability may have been questionable, or where the cover plate was not used, Medtronic is recommending that device stability and screw anchoring be assessed during regular post-operative follow-up visits. These patients should be closely monitored for any signs of early migration. In the rare cases where migration occurs, it is typically within the first four months following surgery.
• Medtronic is not recommending removal of the Intrepid Intervertebral Body Fusion device unless it is warranted in the medical judgment of the physician.