What is the NuVasive MAGEC System?
The NuVasive MAGEC System is a type of magnetic growing rod system used to treat Early Onset Scoliosis.
Headquartered in San Diego, NuVasive is a medical device company focused on developing minimally disruptive surgical products and procedures for the spine.
In September 2017, the U.S. Food and Drug Administration determined (in accordance to provisions of the Federal Food, Drug, and Cosmetic Act) that an updated version of the NuVasive MAGEC System was substantially equivalent to other legally marketed devices and did not require approval of a premarket approval application.
NuVasive MAGEC System Complications
The NuVasive MAGEC System may be an appropriate treatment option for some patients who suffer from EOS. However, some reports indicate serious complications associated with the magnetic growing rods.
A number of peer-reviewed articles have examined potential complications related to the MAGEC system to treat EOS. Those complications may include:
- Metallosis – According to articles published in The Bone and Joint Journal in December 2016 and June 2017, researchers noted significant tissue metallosis surrounding some implants associated with metal debris from the growing rods. Metallosis occurs when metal debris enters the soft tissues of the body. Symptoms of metallosis may include pain, pseudo tumors, and tissue death.
- Actuator pin fracture – Subtle fractures may occur in the distraction element of the growing rods. According to an analysis of two case reports published by The Spine Journal in 2016 and an analysis of explanted devices published in the UK journal Spine, researchers noted evidence of a number of cases in which drive pins within the devices’ actuator fractured.
- Revision surgery – In some cases, revision surgery may be necessary to correct any issues with the growing rods. Revision surgeries often carry an increased risk in a patient’s vulnerability to other complications in addition to any added financial burdens.
Additionally, surgery to implant the MAGEC system is considered to be a major operation. General risks associated with the devices may include bending, loosening, moving, or breaking of implant; allergic reaction to implant materials (such as titanium); worn skin; infection or surgical wound complications; and pain or discomfort.
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Medical device makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a medical device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by a defective NuVasive MAGEC System may be eligible to recover money for:
Medical Expenses Lost Wages Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.