Medtronic CD Horizon Agile Dynamic 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.

All 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.