Medtronic® CD Horizon Agile Dynamic Stabilization Device Recall
What’s the problem?
The 2007 recall of the Medtronic CD Horizon Spinal System Agile Dynamic Stabilization Device was initiated literally months after the device was approved by the US Food and Drug Administration (FDA). And because the Medtronic CD Horizon system was substantially similar to other devices already on the market, manufacturer Medtronic Sofamor Danek did not require approval of a pre-market approval application (PMA) for its Class II medical device.
The devices can fail if not used in appropriate applications. Greater risk is associated with the degree of instability, whether it is pre-existing or created at the time of surgery. Breakages may result from traumatic events such as a fall, or in extreme scenarios which include, but are not limited to the following:
- use in active translational disease in the form of very unstable spondylolisthesis
- angular deformities (such as the apex of scoliosis)
- improper screw placement and rod tightening technique
These situations have led to some occurrences of a shear failure of the cable component of the CD Horizon Agile Dynamic Stabilization Device. This cable breakage could result in return of symptoms (leg and/or back pain) or irritation of local tissues due to displaced components. If no revision surgery is performed, there is a possibility of advancement of the degeneration at the treated level or a potential reaction due to excessive wear debris.
Patients receiving the CD Horizon Agile Dynamic Stabilization Device should be monitored for any symptoms not anticipated from the procedure, such as increased discomfort or any sudden change in their clinical symptoms. As physicians monitor their patients’ progress, they should instruct their patients to contact them if any new symptoms are noted.