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Medtronic CD Horizon Agile Dynamic Stabilization Device

Medtronic Sofamor Danek USA Inc. recalled its CD Horizon Spinal System Agile Dynamic Stabilization Device for spinal fixation in December 2007. 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.

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Medtronic CD Horizon Spinal Stabilization Device

The recalled CD Horizon spinal system Medtronic device was to be surgically attached to the spine for the purpose of alleviating pain in the back and legs through stabilization and was used as an adjunct to spinal fusion of the thoracic, lumbar and sacral spine for degenerative disc disease.

Back PainAll lots (REF 7901000, 10mm, 5.5mm dia x 100mm, size: 10mm x 100mm) of the CD horizon legacy spinal system were recalled.

Cable Breaks Causing Injury

Patients implanted with this device have a pre-existing, severe spinal degeneration problem. If the patient experiences a cable break, there may be a new back injury with new/different manifestation of back pain.

The FDA said that in December, 2007 Medtronic Sofamor Danek, based in Memphis, TN., sent a recall letter to all Risk Managers who received the product at their hospital. Letters were also mailed to surgeons who have implanted the product. Sales Representatives were notified via a conference call and letter to follow-up with their respective surgeons who have implanted the product to verify that their surgeon received the communication of the recall and that they are aware that patient monitoring is recommended.

The number of CD horizon legacy spinal systems on the market is uncertain, but it could be as high as 200,000. The Medtronic spinal stimulator was distributed worldwide, including the USA, Canada, India, Venezuela, Netherlands, Chile, Brazil, and Australia.

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MEDTRONIC CD HORIZON LEGAL ARTICLES AND INTERVIEWS

Medtronic CD Horizon: Caveat Emptor
Medtronic CD Horizon: Caveat Emptor
October 14, 2009
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.
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Patient must have Medtronic CD Horizon spinal system Removed
Patient must have Medtronic CD Horizon spinal system Removed
October 1, 2009
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.
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Failed CD Horizon System Fast-Tracked to Approval, Manufacturer Played by the Rules
Failed CD Horizon System Fast-Tracked to Approval, Manufacturer Played by the Rules
September 22, 2009
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.
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READER COMMENTS

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The device broke, and I was not made aware until nearly two years later. I have constant pain and am unable to move without pain in spinal areas, thigh, and lower legs. Very painful rising from handicap comode. Bending is nearly impossible.

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