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NuVasive MAGEC Lawsuit

NuVasive MAGEC Lawsuit

The NuVasive MAGEC System is a magnetically-controlled titanium rod that treats severe scoliosis in children. Unfortunately, there are reports of MAGEC rods failing, breaking, causing metallosis (metal poisoning), or needing unplanned revision surgery.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting NuVasive MAGEC System induced injury cases in all 50 states. If you or somebody you know has been diagnosed with severe side effects or needed surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

UPDATE: MAGEC System Linked to Biocompatibility Concerns

In July 2021, the FDA issued a Safety Communication about a risk of tissue incompatibility (biocompatibility) associated with components of the following NuVasive Specialized Orthopedics’ MAGEC devices:

  • MAGEC Spinal Bracing and Distraction System
  • MAGEC 2 Spinal Bracing and Distraction System
  • MAGEC System
  • MAGEC System Model X device
  • MAGEC System Model X rod
  • MAGEC System Rods

What is the Problem?

In February 2020, NuVasive issued an Urgent Field Safety Notice to recall MAGEC devices to fix a mechanical failure where the endcap was separating from the rod. In July 2020, the FDA approved a new version of the MAGEC Model X rod. Unfortunately, new biocompatibility problems emerged in December 2020 when NuVasive issued an updated Field Safety Notice and the FDA began receiving reports in early 2021 describing local tissue reactions.

MAGEC Rods Release Titanium and Metal

January 2018 — A new study of the MAGEC Rod System for children with early-onset scoliosis has found that it “significantly releases titanium and possibly aluminum,” and also releases the metal vanadium. Click here to read more.

What is Early-Onset Scoliosis?

Scoliosis is widespread in the U.S., with 2-3% of people having some degree of spinal curvature. In severe cases, scoliosis can cause life-threatening heart and lung disorders, so it must be treated surgically. The most serious type is Early-Onset Scoliosis (EOS), diagnosed in children under 10 years old. EOS almost always requires multiple surgeries to correct the curvature of the spine as the child grows.

Childhood Scoliosis Treatments

Traditionally, children with scoliosis had titanium rods implanted along their spine. Because the rods couldn’t be lengthened, the child would need surgery every 6 months to remove and replace the rod. Another treatment utilizes “growing rods.” As the child grows, they undergo routine surgeries for the purpose of lengthening the rods.

What is the NuVasive MAGEC System?

NuVasive, Inc. of San Diego, California, is a medical device company that designed the MAGEC System — a non-invasive alternative to the traditional surgical treatments for young children with severe scoliosis.

How Does it Work?

The MAGEC rod is designed to slide on 2 guide-rails and expand over time as the child grows. Every 3 to 6 months, a doctor will use a powerful magnet to lengthen the rods in a “short, non-invasive procedure that takes place in a doctor’s office,” according to experts at the Children’s Hospital of Philadelphia.

NuVasive claims that the MAGEC rod eliminates the need for multiple surgeries, unlike “growing rods” or implanting larger rods, avoiding the life-threatening risks of surgery. When the child stops growing, the MAGEC rod is removed and the child has a permanent spinal fusion.

Reports of MAGEC System Failures

Unfortunately, there have been many reports of failing MAGEC rods causing dangerous complications in children. Studies are now investigating long-term risks and side effects of the MAGEC System. Some of the most serious MAGEC System complications include:

  • Metallosis (metal poisoning in the blood)
  • Broken rods
  • Rods failing to lengthen or expand
  • Rods bending or separating
  • Drive pin fracture
  • O-ring seal failure
  • Anchor failure
  • Fractured pin used to stabilize the rod
  • Loose hardware
  • Revision surgery

MAGEC Metallosis / Metal Poisoning

Metallosis is a serious condition that occurs when the MAGEC System corrodes and releases metal into the body or bloodstream. Unfortunately, the MAGEC system can wear out prematurely and release tiny particles of titanium metal into tissues around the implant.

Health Risks of MAGEC System Metallosis

As a result of metallosis and other side effects of the MAGEC failure, patients are at risk of developing extreme pain around the implant, swelling, inflammation, necrosis (tissue death due to metal poisoning), skin pigmentation or discoloration, and requiring unplanned surgery.

Studies Find Metallosis in MAGEC Patients

The problem with the MAGEC System is that metal-on-metal parts grind together when rods are extended. In a study of 34 patients, all 34 had significant metal debris around the implant.

Furthermore, in 53% of the rods, doctors noted “O-ring seal failure.” The O-ring is supposed to prevent titanium particles in the implant from being released into the patient’s body. The researchers warned:

“The combination of high volumes of titanium wear debris alongside O-ring seal damage likely accounts for the metallosis reported clinically around some MAGEC rods.”

In another study of 5 patients with the MAGEC System who needed an unplanned revision surgery, “metallosis was found during revision in 4 out of 5 patients,” and the researchers warned:

“This study highlights concerns with tissue metallosis in [magnetic controlled growing rods]. We recommend careful follow-up of patients who have received this implant.”

Unplanned Surgery for MAGEC Rods

MAGEC is widely-advertised as “less surgery for kids with severe scoliosis,” according to Seattle Children’s Hospital — but from 2014 to 2016, surgeons at the San Diego Spine Foundation followed 23 patients with MAGEC rods, and 11 suffered significant complications. Ten of the children (43%) required an unplanned revision surgery.

Broken MAGEC Rods and Failure to Lengthen

In another study published in The Spine Journal, 6 out of 8 children (75%) with MAGEC rods were forced to undergo unplanned revision surgeries. Two patients suffered broken rods, 1 child suffered a broken rod drive pin, and 1 rod failed to lengthen.

Long-Term Complications of Metallosis

As metal particles accumulate around the implant, the patient can experience pain, swelling, and inflammation. If metal gets into the bloodstream and circulates throughout the body, metallosis can cause:

  • Vision and hearing problems
  • Cognitive impairment
  • Nerve damage
  • Heart failure
  • Thyroid problems
  • Skin rashes
  • Infection
  • Unknown long-term effects in children

Can Metallosis Cause MAGEC Failures?

Tissue damage from the accumulation of metal around an implant (metallosis) is a major cause of premature failure of implanted medical devices, according to study in Clinical Orthopaedics and Related Research.

FDA 510(k) Approval for MAGEC System

NuVasive received a 510(k) clearance for the MAGEC System, which means that the FDA approved it without requiring substantial safety studies or clinical trials. This is because NuVasive claimed that the MAGEC System was “similar” to older rods that were already on the market. The problem is that “similar” devices are not necessarily safe.

What is the problem?

Surgery may be necessary if the NuVasive MAGEC rod breaks, fractures, bends, or fails to lengthen. In some cases, the rod may need to be removed completely. If the MAGEC rod corrodes or wears out prematurely, a child may develop metallosis (metal poisoning) — as well as long-term side effects that will require ongoing treatment, possibly for the rest of the child’s life.

Do I have a NuVasive MAGEC Lawsuit?

The Schmidt Firm, PLLC is currently accepting NuVasive MAGEC System induced injury cases in all 50 states. If you or somebody you know has been diagnosed with severe side effects or needed surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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