FDA Warns of Attainable Mechanical Issues With MAGEC Devices
The US Meals and Drug Administration (FDA) has issued a gape about likely mechanical mess ups and biocompatibility issues with MAGEC machine devices from NuVasive.
MAGEC is a surgical magnetic rod machine faded to tackle early-onset scoliosis (EOS) in children underneath 10 years of age. The magnetic machine can abet steer obvious of invasive surgeries, as growth rods might maybe even be adjusted with an external faraway shield watch over. MAGEC is the acceptable FDA-current pure distraction-primarily based fully mostly machine for EOS and is basically the most-faded technology for EOS therapy in US, Aakash Agarwal, PhD, director of compare and medical affairs at Spinal Stability Inc in Swanton, Ohio told Medscape Clinical News in an email.
In step with the awareness, there are reports of endcap separation and O-ring seal failure within the following six 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 Mannequin X Machine
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MAGEC System Mannequin X Rod
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MAGEC System Rods
Endcap separation can potentially expose the patient’s tissue to inner substances of the instrument which comprise no longer been fully examined for biocompatibility.
In February 2020, NuVasive recalled its MAGEC System Mannequin X rods to tackle reports of endcap separation points. The FDA cleared a modified version of the instrument designed to mitigate these occasions in July 2020. In April of this one year, NuVasive knowledgeable providers of likely biocompatibility issues and positioned a voluntary shipping address the MAGEC instrument machine. The shipping take became once lifted the day gone by, the firm offered.
The FDA is currently no longer recommending removal of functioning MAGEC devices, noting that it is “within the acceptable ardour of sufferers” to continue to fetch the machine on hand. The total advantages of the instrument outweigh the recognized risks, and the restricted use for a 2-one year implantation time for teens underneath 10 years of age will extra mitigate these risks, the FDA said within the assertion.
To yarn opposed occasions connected to MAGEC devices, sufferers, caregivers, and providers can post a yarn thru MedWatch, the FDA Security Data and Adverse Tournament Reporting program.
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