Failed CD Horizon System Fast-Tracked to Approval, Manufacturer Played by the Rules

Washington, DCThe recall almost two years ago 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 CD Horizon spinal system device is surgically attached to the spine to relieve pain in the back and legs through stabilization and was designed as an adjunct to spinal fusion of the thoracic, lumbar and sacral spine for degenerative disc disease.

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.

Understanding the CD Horizon Spinal System Approval Process

The approval process of the Medtronic spinal device is revealing. In two separate communiqués to the FDA, one dated November 2006 and the other a month later, Medtronic Sofamor Danek of Memphis, Tennessee apprised the FDA of its new device and ended each letter with reference to documentation summarizing a risk analysis, together with the claim that the stabilization device was 'substantially equivalent' to instruments previously cleared, approved and on the market.

Such a statement of substantial equivalence is key, given the provisions of the Federal Food, Drug and Cosmetic Act.

In a letter date-stamped January 18th 2007 and posted on the FDA web site, the FDA Supervisor for Regulatory Affairs stated in comments to Medtronic, " We have reviewed…and determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).

"You may, therefore, market the device, subject to the general controls provisions of the Act."

Six months later, on November 12th 2007 all lots of the CD Horizon Spinal System were recalled for shear failure of the cable component inherent with the system. As of September 11th 2008, the date at which the FDA posted the recall, there were 231 units 'in commerce,' according to the FDA.