The U.S. Food and Drug Administration (FDA) issued a safety communication detailing the recent recall of the NuVasive Specialized Orthopedics MAGEC devices. Potential mechanical failures and tissue incompatibility have been identified with various components of the device systems.
The recall involves the following devices: MAGEC Spinal Bracing and Distraction System; MAGEC 2 Spinal Bracing and Distraction System; MAGEC System; MAGEC System Model X device; MAGEC System Model X rod; MAGEC System Rods.
What is MAGEC?
MAGEC is a growing spinal rod system. It is intended for use in children who are 10 years of age and younger. They help correct spinal deformities the child may experience as they grow up. Its purpose is to lessen the number of operations to correct spinal curve.
Risks Associated with MAGEC Devices
There is a risk of endcap separation, O-ring seal failure, and adverse local tissue reactions due to potential exposure of internal components of the devices. Should any of this happen, revision surgery will more than likely be prescribed which could put your family out thousands of dollars.
Endcap separation is the unanticipated exposure of a patient’s tissue to the internal components of the MAGEC device. These components have not been tested for biocompatibility. Endcap Separation was addressed by NuVasive in 2020, but still poses a risk and threat of further health issues.
In April 2021, NuVasive issued a global ship hold on its devices due to biocompatibility testing concerns. Although NuVasive initially placed that ship hold on all MAGEC devices, by July 2021 it was lifted and they were available on the market again. The FDA believes the benefit of MAGEC devices in patients outweighs the risk. However, this does not mean MAGEC is entirely in the clear.
Metallosis occurs when medical debris enters the tissue and blood. This is one of the primary biocompatibility concerns with MAGEC devices. It can cause pain, inflammation, and swelling in the surrounding tissue. In some cases, this can cause premature failure of the MAGEC device.
NuVasive already issued an urgent field safety notice in February 2020 which recalled MAGEC devices. The problem was the mechanical component failure– the endcap was found to separate from the rod part of the device.
Though the FDA cleared the modified version of the MAGEC Model X rod in July 2020, by December of the same year problems started to arise again. NuVasive updated their field safety notice for customers in the European Union. In early 2021, reports started to come in that described local tissue reactions related to the endcap separation previously found in MAGEC devices.
FDA Recommendations
For patients that have the MAGEC devices already implanted, the FDA does not recommend removal two years after implantation.
Questions About a NuVasive MAGEC Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
If you or someone you love has been implanted with a NuVasive MAGEC device, and have experienced a complication or side effect, you should contact our lawyers today. You may be entitled to financial compensation by filing a NuVasive lawsuit.
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