The CD Horizon Spinal System Agile Dynamic Stabilization Device was recalled by the manufacturer in December 2007, just months after it was approved by the FDA. Medtronic has admitted that its device is prone to failure, shearing and cable breaks, which could result in increased pain in the back and legs and/or require removal and replacement surgery of the stabilization devices.
The Medtronic CD Horizon Spinal Device System
Spinal fusion is a process using bone graft to cause two opposing vertebrae to grow, or “weld,” together. To ensure position and rigid alignment while fusion takes place, surgeons apply spinal instruments, or implants, such as screws and rods to the spine. These implants are joined together to maintain spinal stability and are rarely removed. Spinal fusion and implants are used to restore stability to the spine, correct deformity and bridge spaces created by the removal of damaged spinal elements such as discs.
The Medtronic CD Horizon Spinal Device is an implant system composed of rods, screws, specially designed surgical tools and a novel mechanical implant delivery device. This device looks much like the sextant of naval navigation, and is the navigation and insertion tool that allows screws and rods to be applied to the spine in a minimally invasive manner.
Medtronic Spinal Device Recall
The recall almost three years ago of the Medtronic Spinal Device was initiated mere months after the device was approved by the FDA. Because the 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 device was on the market for less than a year when cables associated with the device were found to be prone to failure. Medtronic immediately recalled all lots of the device and alerted surgeons, hospitals and the medical community at large, as well as the FDA.