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.
Questions?
If you have questions about this FDA Safety Communication, contact the Division of Industry and Consumer Education.
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