Thursday, July 15, 2021

Potential Concerns with MAGEC System Implants - FDA Safety Communication

Read about potential concerns with MAGEC implants related to endcap separation and gaps in biocompatibility testing.

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FDA - Center for Devices and Radiological Health

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.

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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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