Sometimes Medical Devices intended to help actually hurt. Such is the Case for NuVasive.
EOS is a serious medical condition because it occurs when a young child’s skeletal structures are still developing. If the spinal curvature is not treated and becomes severe, it can constrict the child’s thorax or chest cavity causing them breathing issues and restricting the growth of their lungs. Therefore, EOS treatments must control the spinal deformity while also allowing the spine to grow.
The NuVasive Magec System is marketed as an alternative surgical treatment for children with moderate to severe EOS and promises “noninvasive growth modulation.” It is important to not that in the case of the NuVasive System, the fact that the FDA has "approved" the device, does not guarantee or warranty it safety. The device is a magnetic controlled growing rod system, which, in theory, expands to help straighten and correct the curvature of the spine as the child grows.
NuVasive Specialized Orthopedics, the company standing to profit from the device, claims its magnetic rod technology significantly reduces the number of surgical procedures EOS patients require compared to traditional treatment options. However, clinical results have shown that this may not be accurate given the increasing complication rates.
Early issues with the NuVasive system are especially concerning given the young age of the patient population. Parents are being led to believe that this treatment option is safe for their child, but researchers and clinicians are seeing major failures with the spinal device and raising concerns regarding the device’s potentially high complication rates.
In addition, the U.S. Food and Drug Administration (FDA) continues to receive reports of issues with the NuVasive Magec System that include:
- Rods failing to properly extend or expand
- Rods not engaging properly
- Rods bending, breaking or separating
- Fractures of the pins used to stabilize the rod
NuVasive Specialized Orthopedics, Inc., has the full responsibility to its pediatric patients and their families. The company, in order to comply with Illinois and Federal law, must ensure these medical devices perform as indicated and do not endanger the health of the children undergoing treatment with these devices.
Due to the large numbers of these devices entering the marketplace and being implemented on children, Koester & Bradley is investigating all adverse events related to the NuVasive Magec System. Please reach out to us for a free review of your case and stay up to date on the other defective products cases we are presently handling.