Some NuVasive MAGEC devices, which brace the spines of children with scoliosis, have been recalled since 2020. NuVasive reportedly fixed the previous mechanical problems but the FDA has still received complaints about other injury risks associated with NuVasive MAGEC devices. The most recent FDA warning isn’t a mandatory recall, though it suggests the issues with MAGEC devices may result in serious injury.
The Lyon Firm litigates medical device injury cases nationwide on behalf of plaintiffs. Following any safety issues with a NuVasive MAGEC device, call for a free case review.
What is the NuVasive MAGEC System?
The NuVasive MAGEC System is a device implanted into a patient to brace the spine during growth. The device is meant to minimize the progression of scoliosis, and treat early-onset scoliosis in children under age 10 when nonoperative treatment has failed.
The NuVasive MAGEC system works by implanting adjustable growth rods into a patient. Magnets and a remote control the rods, which helps straighten the spine as a patient grows. The implants, however, may loosen, fracture, corrode, migrate, or cause serious pain.
NuVasive MAGEC Recalls
As stated in the reason the FDA recall, 0.5% of NuVasive MAGEC devices have experienced a separation of the rod’s actuator end cap components. This separation may lead to the degeneration of its internal components.
In February 2020, NuVasive issued an Urgent Field Safety Notice thereby recalling MAGEC System Model X rods. The safety notice recommended that healthcare providers examine their inventory, quarantine affected products, and cease implantation of Model X rods. For patients who had already undergone NuVasive MAGEC Model X implantation, the company recommended that patients follow appropriate postoperative procedures. Patients should also assess the device via X-ray imaging every six months.
In December 2020, NuVasive issued an updated Field Safety Notice indicating the MAGEC System could experience “locking pin breakage, O-ring seal failure, generation of metal wear debris, and failure of the rod to distract.” Physicians and patients were encouraged to consider the use of the NuVasive MAGEC system in the European Union only.
In April 2021, NuVasive notified healthcare providers of “biocompatibility concerns” of its components. The FDA received complaints of local tissue reactions possibly related to MAGEC endcap separation.
In July 2021, the FDA issued a warning concerning potential NuVasive MAGEC mechanical failures and tissue incompatibility that can occur upon exposure to these components. The warning covered several NuVasive MAGEC system products and MAGEC System Model X devices, including:
- MAGEC System Model X Rods
- MAGEC System Rods
- MAGEC Spinal Bracing and Distraction System
- MAGEC 2 Spinal Bracing and Distraction System
Defective medical devices can pose a significant safety hazard to patients. Besides adverse reactions related to component exposure, the long-term efficacy of the NuVasive MAGEC device remains unknown. Any defect could lead to the potential need for additional surgeries.
Technological advancements in medical science have delivered hundreds of new medical devices in recent years. When they are necessary for ailing patients, health care providers and patients rely on the judgment, honesty, and skill of medical device manufactures to offer safe products. However, not all of these medical devices have been tested, and many have proved defective, injuring thousands of patients who trusted the companies who marketed the so-called safe products.
Medical Device Defect Lawsuits
Because many of the medical devices on the market may be inadequately tested and rushed to the consumer to make a profit, victims and attorneys have filed many claims against the responsible companies. When manufactures are negligent and injure patients with defective medical devices, litigation is often necessary to restore the financial and human loss that is endured.
Although the U.S. Food and Drug Administration (FDA) is responsible for making sure that medical devices are adequately tested, device recalls have become increasingly common. Device manufacturers are often slow to respond to consumer complaints and must be held responsible for injuries caused.
Defective medical device litigation provides answers when medical device companies are unwilling to be honest with consumers and their physicians about the risks and dangers of their products.
Many medical device companies have been involved in medical device litigation for defective produce designs and failure to adequately warn claims. The litigation often precedes a voluntary recall. Many critics have argued that the lenient FDA 510K process is partly to blame for the increase in medical device defects and injuries reported.