Medtronic Sofamor Danek USA Inc. recalled its CD Horizon Spinal System Agile Dynamic Stabilization Device for spinal fixation in December 2007 because it was found to be 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. All lots (REF 7901000, 10mm, 5.5mm dia x 100mm, size: 10mm x 100mm) of the CD horizon legacy spinal system were recalled.
It has been found that the devices can fail if not used in appropriate applications. Breakages may result from traumatic events such as a fall, or in extreme scenarios. These situations have led to some occurrences of a shear failure of the cable component of the CD Horizon Agile Dynamic Stabilization Device.
Resulting problems include return of symptoms (leg and/or back pain), or irritation of local tissues due to displaced components. If no revision surgery is performed, there is a possibility of advancement of the degeneration at the treated level or a potential reaction due to excessive wear debris.
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