FDA Notice Raises Potential Safety Concerns With NuVasive Magec Spinal Rod System
On July 15, 2021, the FDA issued a notice warning patients, caregivers, and health care providers of potential safety issues posed by the NuVasive Magec spinal rod system. According to the FDA announcement, several mechanical failures have been associated with the systems, including endcap separation, O-ring seal failure, and potential exposure of internal components to a patient’s living tissue. The mechanical failures have raised biocompatibility concerns related to the potential for metal debris to accumulate around the implanted rod, which could expose the patient’s body to metal contamination. A patient exposed to harmful metal buildup may suffer from metal poisoning of the blood (metallosis), tissue or bone damage, tissue death (necrosis), among other things. Further, a patient may require additional surgery to address the failure.
How Was the NuVasive Magec System Used?
The Magec system was introduced to treat the spinal curvature of children under 10 years old with early onset scoliosis. The NuVasive Magec system consists of metal rods that are surgically implanted into a young scoliosis patient’s back to help correct spinal deformities as the child grows. Magec devices utilize magnets to lengthen the rod as the child grows. The magnet system was intended to reduce the number of surgeries required by traditional scoliosis treatment options. Unfortunately, the system has been associated with mechanical failures that could lead to severe health complications.
If your child has suffered injuries or undergone you suspect were caused a failure of the NuVasive Magec spinal rod system, contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers have a proven history of results for thousands of clients nationwide. They possess the knowledge, resources, and skill needed to get you the justice and compensation you deserve. Call 513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.