Medical Device Recall Alert for the NuVasive MAGEC® X Rod

March 10, 2021—San Diego, CA.  The lawyers at Schmidt National Law Group have been alerted to the potential dangers and problems of the faulty NuVasive MAGEC® X Rod used in children needing onset scoliosis treatment. 

NuVasive’s MAGEC® X product first came to market in 2018 in the U.S. This faulty product could have affected many children since more than 100,000 children are diagnosed with scoliosis each year in the United States.

The complete recall of the NuVasive’s MAGEC® X Rod system was initiated by the company on February 13, 2020 after reports of an actuator cap component separating after installation which could lead to various injuries such as:

• Blood poisoning via metallosis
• Rods breaking or bending after being installed
• Parts corroding internally
• Separation of mechanical parts   
• Failure of the rods to lengthen during doctor’s visit.

This is a Class 2 Device Recall listed on the FDA website.

NuVasive had issued its first safety notice in 2019 and in a public address on its website where it listed the following warnings and precautions:

• Metallic implants can loosen, fracture, corrode, migrate, or cause pain.
• Use of the MAGEC® Rods may result in localized tissue discoloration.
• Device should be removed after implantation time of no more than six years.
• Device should be removed if skeletal maturity has been reached, or active distraction period has ended.
• Device should be removed and/or replaced if maximum distraction length of device has been achieved, and patient is still in active growth phase.
• During period of implant, patient should not participate in contact or severe sports such as weightlifting, tumbling, gymnastics, rowing, or other high risk activities.
• During period of implant, patient should limit backpack weight to 20% of body weight or less.
• During period of implant, patient should limit backpack weight to 20 lb (9 kg) or less.
• Patients should be limited to those having a BMI (body mass index) of 25 or less.
• Ensure that the distraction length is assessed by X-ray imaging immediately after non-invasive adjustment procedure, and also at a minimum of once every six months.    

The problems with the faulty device were manufactured before March 26, 2015. Those devices suffered from a defect of a fractured locking pin thus causing separation of the internal components and the extension of an internal component from the device housing. (Source link below)

If you are unsure if you child has one of these defective MAGEC® X Rods we can help determine that.

However since the release of the information above, issues with newer MAGEC® X versions began to surface.

In February the company said its internal data illustrated a 0.5% of its devices had been affected by the actuator end cap separation, thus leading to it to deteriorate at a faster rate, and that tissue of the patient to discolor from the titanium alloy used. This could also lead to metallosis problems due to metal bits entering the bloodstream.

Has a member of your family been injured or hurt from a defective MAGEC® X Rod?

If your child has been hurt, injured or needed revision surgery due to the faulty MAGEC® X Rod product, we can provide you financial compensation for your child’s pain, suffering and emotional stress caused by this device. Learn more about the MAGEC Rod Lawsuit Claims & Settlements.

Due to the lack of warning to the public we will hold NuVasive accountable.  

No child or family should have to go through a revision surgery and face further time in a hospital due to manufacturers neglect in proper design of a medical device. We’re standing by to help, contact us today at 1-800-631-5656 or use the secure contact form on this page.

Source links:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=181098

https://mhra-gov.filecamp.com/s/UqEZkJEZumn00af1/d/MNATzAHuPipfk9k0