The Food and Drug Administration (FDA) issued a safety communication regarding potential mechanical failures and concerns about biocompatibility associated with components of the following NuVasive Specialized Orthopedics MAGEC devices:
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MAGEC Spinal Bracing and Distraction System
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MAGEC 2 Spinal Bracing and Distraction System
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MAGEC System
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MAGEC System Model X device
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MAGEC System Model X rod
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MAGEC System Rods
MAGEC is a growing spinal rod system intended for use in children under 10 years of age. MAGEC devices use magnets to help correct spinal deformities as the child grows. They are designed to help avoid multiple operations to correct the spinal curve. MAGEC devices are intended to be implanted only in skeletally immature patients less than 10 years of age with severe progressive spinal deformities associated with or at risk of thoracic insufficiency syndrome, and are cleared for implantation for no more than 2 years.
In February 2020, NuVasive issued an Urgent Field Safety Notice recalling its MAGEC devices to address a mechanical component failure where the endcap was separating from the rod part of the device. In July 2020, the FDA cleared a modified version of the MAGEC Model X rod, designed to mitigate endcap separation events. Additional biocompatibility concerns potentially related to the existing endcap failures were raised in December 2020, when NuVasive issued an updated Field Safety Notice intended for customers in the European Union. In addition, the FDA began receiving reports in early 2021 describing local tissue reactions potentially related to endcap separation events with the MAGEC devices.
As NuVasive continues to investigate the root cause of these issues, the FDA is working with the manufacturer to evaluate new biocompatibility testing results and assess whether there is any clinically meaningful impact to patients with MAGEC devices. The FDA believes the benefits of a MAGEC device outweigh the risks for U.S. patients based on the current FDA-cleared indications for use and labeling. Indications for use and labeling may vary in other countries. At this time, the FDA does not recommend the removal of functioning MAGEC rods prior to the 2 years after implantation. If a patient experiences increasing levels of unexpected back pain with a MAGEC device, the health care provider should perform an additional examination of the patient’s back, including obtaining x-rays to evaluate the condition of the MAGEC implant.
Food and Drug Administration (FDA). Potential Concerns with NuVasive MAGEC System Implants – FDA Safety Communication. July 15, 2021. Available at: click here. Accessed July 15, 2021.