Medtronic CD Horizon Spinal System: Buyer Beware
September 28th, 2009. By LucyC
We’re approaching the two year anniversary of the FDA recall of all lots of the MedTronic CD Horizon Spinal System Agile Dynamic Stabilization Device. So why bring it up? Well, in light of the seemingly endless number of defective products that make their way onto the market every year, the CD Horizon provides a cautionary tale.
The device was developed to relieve spinal pain, and was surgically implanted. Sadly, the CD Horizon spinal system was prone to failure, causing patients more pain rather than less.
The device was approved on the strength of risk analyses by Medtronic which allegedly claimed the device was “substantially equivalent” to instruments the FDA had already approved. The FDA, having reviewed the device, approved it for market subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act, that do not require premarket approval application.
Yes, you read that right. The FDA appears to have approved the device for its intended use without either doing or requiring any rigorous product safety testing be done.
Then, in November 2007, just six months after the FDA approved the device, all lots were recalled because the cable component within the system was shearing.
So, given that the checks and balances that are supposedly in place to protect consumers can be, in situations like this, not up to the job, protecting your well-being becomes your responsibility. Or—as the Romans so accurately put it over 1000 years ago—Caveat Emptor. If you are considering some kind medical implant ask about the safety data, and get a second opinion.
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