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# FDA Safety Concerns with NuVasive MAGEC Implants
- URL: https://www.fdaweb.com/fda-safety-concerns-with-nuvasive-magec-implants/
- Published: 2021-07-15T12:00:00.000Z
- Updated: 2026-09-14T17:06:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149725

FDA says patients, caregivers, and healthcare providers should be aware of potential mechanical failures and concerns about tissue incompatibility associated with components of several specified NuVasive Specialized Orthopedics MAGEC devices. An agency [safety communication](https://www.fda.gov/medical-devices/safety-communications/potential-concerns-nuvasive-magec-system-implants-fda-safety-communication?ref=fdaweb.com) refers to a company 2/2020 notice recalling its MAGEC devices to address a mechanical component failure where the endcap was separating from the rod part of the device. FDA cleared 7/2020 a modified version of the MAGEC Model X rod designed to mitigate endcap separation events.

The notice says additional biocompatibility concerns potentially related to the existing endcap failures were raised 12/2020 in an updated company safety notice to customers in the European Union. FDA says it also began receiving reports early in 2021 describing local tissue reactions potentially related to endcap separation events with the MAGEC devices.

The agency says it is working with NuVasive to evaluate new biocompatibility testing results and assess whether there is any clinically meaningful impact to patients with MAGEC devices.

MAGEC is described as a growing spinal rod system intended for use in children under age 10\. It uses magnets to help correct spinal deformities as a child grows. NuVasive says the system is designed to help avoid multiple operations to correct a spinal curve.