The US Food and Drug Administration (FDA) has issued a notice about potential mechanical failures and biocompatibility concerns with MAGEC system devices from NuVasive.
MAGEC is a surgical magnetic rod system used to treat early-onset scoliosis (EOS) in children under 10 years of age. The magnetic system can help avoid invasive surgeries, as growth rods can be adjusted with an external remote control. MAGEC is the only FDA-approved pure distraction-based system for EOS and is the most-used technology for EOS treatment in US, Anand Agarwal, PhD, Director of Research and Clinical Affairs at Spinal Balance Inc in Toledo, Ohio told Medscape Medical News in an email.
According to the notice, there are reports of endcap separation and O-ring seal failure in the following six MAGEC devices:
MAGEC Spinal Bracing and Distraction System
MAGEC 2 Spinal Bracing and Distraction System
MAGEC System Model X Device
MAGEC System Model X Rod
MAGEC System Rods
Endcap separation can potentially expose the patient’s tissue to internal components of the device that have not been completely tested for biocompatibility.
In February 2020, NuVasive recalled its MAGEC System Model X rods to address reports of endcap separation issues. The FDA cleared a modified version of the device designed to mitigate these events in July 2020. In April of this year, NuVasive informed providers of potential biocompatibility concerns and placed a voluntary shipping hold on the MAGEC device system. The shipping hold was lifted yesterday, the company announced.
The FDA is currently not recommending removal of functioning MAGEC devices, noting that it is “in the best interest of patients” to continue to make the system available. The overall benefits of the device outweigh the known risks, and the restricted use for a 2-year implantation time for children under 10 years of age will further mitigate these risks, the FDA said in the statement.
To report adverse events related to MAGEC devices, patients, caregivers, and providers can submit a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
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