Potential Concerns with MAGEC System Implants: FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to inform patients, their caregivers, and health care providers of mechanical component failures and biocompatibility concerns with NuVasive Specialized Orthopedics MAGEC devices.

This safety communication provides: 

• Details about the mechanical component failures and biocompatibility concerns with MAGEC devices. 
• Recommendations for patients and their caregivers. 
• Recommendations for health care providers, including discussions with patients and their caregivers. 
• Actions the FDA is taking to address safety concerns with MAGEC devices. 
• Instructions for reporting problems with MAGEC devices to the FDA.  

Questions? 

If you have questions about this letter to health care providers, contact the Division of Industry and Consumer Education (DICE).