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NuVasive created the MAGEC (Magnetic Expansion Control) to offer a safer treatment option to children with scoliosis. Scoliosis can develop during childhood and is an abnormal curvature of the spine. Severe scoliosis requires children to undergo surgery to implant rods to straighten the spine. Since children are still growing, these rods must be removed and replaced numerous times which requires multiple surgeries and can lead to complications and increased risks.

NuVasive has recalled its MAGEC System Model X rods due to serious potential complications including:

  • titanium metallosis (a type of blood poisoning)
  • necrosis (tissue death)
  • tissue damage
  • premature implant failure (the device not remaining effective and safe over the expected lifespan of the product)
  • potentially multiple unplanned and painful revision surgeries

The root cause of these problems is currently under investigation.

The MAGEC System was touted as a more appropriate option because it reduced the number of surgeries required over a child’s period of growth. This was because MAGEC was a magnetically controlled rod that could be lengthened in a doctor’s office, without the need for surgery under general anesthesia.

Doctors are being advised to review their inventory to see if they currently have any MAGEC System Model X rods in stock and to return them immediately.  Surgeons are also being advised to not implant Model X rods until further notice, and to follow up and discuss potential clinical implications and risks with patients who received affected rods.

If your child has suffered complications as a result of an implanted NuVasive MAGEC System, please contact our experienced team.