NuVasive MAGEC System | Early treatment of scoliosis, potential side effects

What is the NuVasive MAGEC System?

The NuVasive MAGEC System is a medical device that treats children with early scoliosis (EOS). Children with EOS have a spine that grows in curves or twists instead of straight. EOS affects children before the age of 10.

The FDA approved the system in 2017 for patients with progressive or severe OSA who failed non-operative treatment.

MAGEC stands for MAGnetic Expansion Control. The MAGEC system is composed of adjustable cultivation stems controlled by magnets and an external remote control. A surgeon implants the growth stems into a child’s back to help straighten the spine and keep it upright as the child grows.


TO EXPAND

The NuVasive MAGEC System helps straighten the spine in children with early scoliosis (EOS).

How MAGEC treats early scoliosis

Doctors have been using growth sticks to treat EOS for several years. Surgeons implant two growth stems on either side of the spine. As children grow older, the stems should be lengthened every six months to aid in the growth and straightening of the spine.

This process of lengthening and stretching the spine with implants is called distraction. Children implanted with traditional growth stems must undergo distraction surgery every six months on average to adjust the stems as they grow.

With the MAGEC system, doctors once implant special titanium growth rods into a child’s back. This allows doctors to gradually stretch the spine using a remote control and strong magnets, without several invasive surgeries. This non-invasive distraction technique is a generally quick and painless outpatient procedure.

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Surgery to implant the MAGEC System typically takes about two hours under general anesthesia.

Potential side effects of the MAGEC system

There are not enough studies to determine how often side effects from the MAGEC system occur. But a 2020 study in the Journal of Pediatric Orthopedics reported that 10 of 39 study participants implanted with the MAGEC system suffered from implant-related complications.

Another 2020 study in Spine Surgery and Related Research reported that the system has a high failure rate compared to traditional rods. This can lead to unscheduled revision surgery to replace the implant.

The researchers observed that the devices generate titanium debris that can cause metallosis, an inflammatory reaction that causes swelling, pain, and death of the tissues around the implant.

Prosecution Information

Lawsuits are filed by parents and guardians of children who have suffered serious injuries caused by the NuVasive MAGEC system.

See the prosecutions

NuVasive MAGEC Recall Status

In February 2020, NuVasive recalled the MAGEC system because the tip separated from the ends of the rods. The danger of separating the tip is that a patient’s tissue could be exposed to components of the device which may not be biocompatible and may cause adverse reactions in the body.

In April 2021, NuVasive placed all MAGEC devices on global hold until it could assess biocompatibility testing issues. The FDA has approved a new version of the MAGEC X rod to solve the problems with the separation of the plugs. In July 2021, the suspension was lifted and the newly designed MAGEC X is currently the only device available in the United States.

This recall has led to potential lawsuits from the MAGEC System for injuries, including skin discoloration, broken stems, implant failure, and the need for additional painful surgeries.

Prior to this recall, NuVasive issued a recall in June 2019 because the devices had a higher than expected locking pin failure rate of 5%.

Please seek the advice of a healthcare professional before making any healthcare decisions.

  • Presentation of the NuVasive MAGEC system


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