Medtronic CD Horizon Legal News Articles & Interviews

Memphis, TN: Caveat Emptor or "Let the buyer beware" usually refers to the sale of real property after the date of closing. But the doctrine can also apply to Medtronic CD Horizon , an innovative lumbar fusion which was approved by the FDA only based on risk analyses by Medtronic, which allegedly claimed the device was "substantially equivalent" to instruments the FDA had already approved. In other words, it did not require pre-market approval application. That doesn't bode well with patients who may be facing another back surgery to have the defective device removed.

Denver, CO Richard had a CD Horizon spinal system Medtronic device implanted two years ago, just around the time the FDA recalled all lots of the MedTronic CD Horizon Spinal System Agile Dynamic Stabilization Device. "I am furious," says Richard, "because I need to go through another surgery to take it out and a fourth surgery to repair the damage caused by this defective stablization device," he says.

Washington, DC The 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.