SATELLITE™ Spinal System

The Satellite Spinal System is manufactured by Medtronic Sofamor Danek and consists of spheres that can be inserted between spinal vertebras. The system is intended to stabilize and hold together parts of spinal vertebrae while they heal. This is accomplished by fusing the device to a bone graft.

On October 1, 2007, the United States Food and Drug Administration (FDA) sent a warning letter to Medtronic for omitting instructions, and in some cases providing misleading instructions, in an operating manual for one of its implantable medical devices.

Sources: U.S. Food and Drug Administration, “Medtronic Warned Over Surgical Technique Manual, Press Release,” FDAnews Daily Device Bulletin, October 18, 2007; “FDA cites Medtronic for misleading spine surgeons,” Reuters, October 9, 2007.