Magec Rods Lawsuit in 2024 (Latest Updates)

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Update: NuVasive Magec Rods Linked to Mechanical Failures, Incompatibility

According to the Food and Drug Administration on July 15, 2021, the agency issued a warning which stated that the following NuVasive MAGEC devices have been linked to reports of mechanical failure and tissue incompatibility (biocompatibility) [1].

• MAGEC Spinal Bracing and Distraction System
• MAGEC 2 Spinal Bracing and Distraction System
• MAGEC System External Remote Controller
• MAGEC System Model X device
• MAGEC System Model X rod
• MAGEC System Spinal Growing Rods

The FDA is aware of reports describing endcap separation, O-ring seal failure, and of potential exposure of internal components of this device to living tissue that may lead to adverse local tissue reactions, FDA said.

NuVasive Specialized Orthopedics 2020 made changes to the MAGEC device design to address endcap separation problems. The risk associated with endcap separation is unanticipated exposure of the patient’s tissue to internal components of the device that have not been completely tested for biocompatibility.

In July 2020, a medical professional at the FDA cleared a new version of the MAGEC X rod, and this version of the MAGEC X device (MAGEC 2b) is designed to mitigate endcap separation.

In April 2021, NuVasive informed healthcare providers of biocompatibility testing concerns and voluntarily placed all MAGEC devices on a global ship hold. The company lifted the hold in July 2021 because the FDA believes it is in the best interest of patients because:

• The overall benefits of the device outweigh the known risks for on-label use in the U.S. compared to alternative treatments;
• The U.S. indications and instructions for use, which restrict use to patients less than 10 years old and for a two-year implantation time, further mitigate known risks;
• The modified MAGEC X (MAGEC 2b) device, designed to mitigate endcap separation events and related biocompatibility concerns, will be the only device version currently available for sale in the U.S.;
• The U.S. labeling has been updated to include a discussion of known risks associated with the device.

As NuVasive continues to investigate the root cause of these issues, the FDA is working with the manufacturer to evaluate new biocompatibility testing results and assess whether there is any clinically meaningful impact to patients with MAGEC devices, the agency said.

What is the NuVasive Magec Rod?

The NuVasive Magec Rods System is a magnetically controlled growing rod system used to treat severe scoliosis in young children. The technology was designed to eliminate, or substantially reduce, the need for repeated invasive surgical procedures.

Related Article: Precice Stryde Implant Lawsuit

How is the Magec Rod Different from Other Scoliosis Treatments?

Most traditional treatments for scoliosis in children involve surgical implants that “guide” the growth of the spinal column. When children are too young to undergo one of these procedures, but braces or casts are not enough to control their spinal curves, surgeons turn to spinal fusions for treatment.

What’s the Problem with the Device Magec System Model?

Recent studies have linked the NuVasive Magec Rod System and other similar medical devices to adverse health consequences, including the need for invasive revision surgery. This is despite claims by the manufacturers that their products are intended to reduce the likelihood of subsequent intervention.

Nuvasive Magec Rod Complications

Nuvasive Magec System Implants have been linked to the following serious complications:

• Skin discoloration
• Metallosis (shedding of metal particles)
• Necrosis
• Failure of the rods to distract (lengthen) when required
• Bent or broken rods
• Device failure
• The need for painful revision surgery
• Tissue death
• Spinal curvature

Early Onset Scoliosis Surgery

Scoliosis is a severe neuromuscular condition that chiefly manifests in the bones, according to the Mayo Clinic. Most cases of scoliosis reported in the U.S. are relatively mild, but some children develop spine deformities that continue to get worse as they age.

Scoliosis can be permanently disabling, as a severe spinal curve can reduce the amount of space within the chest, making it difficult for the lungs to function properly.

Scoliosis Symptoms

• Uneven shoulders
• One shoulder blade that appears more prominent than the other
• Uneven waist
• One hip higher than the other

If a scoliosis curve gets worse, the spine will also rotate or twist, in addition to curving side to side. This causes the ribs on one side of the body to stick out farther than on the other side.

What is Early Onset Scoliosis (EOS)?

While most scoliosis patients are diagnosed in childhood or adolescence, a small percentage are found to have early-onset scoliosis (EOS), which is diagnosed before age 10. Once a child reaches adolescence, his or her spine is essentially fully developed, according to the Children’s Hospital of Philadelphia (CHOP).

Therefore, EOS occurs while children’s spines are still growing, which is why the condition almost always requires medical intervention.

Diagnosis, Treatment & Statistic

According to this 2022 National Library of Medicine study, to diagnose early-onset scoliosis, x-rays are performed to determine whether the spine has a curvature of over 10%. Roughly one in every thousand people suffers from scoliosis in the U.S. [2].

The 1st surgery performed on EOS patients occurs between the ages of 5 and 7 and typically involves placing a set of growing rods along the spine which can be lengthened over time. The NuVasive Magec

The system is designed to allow the rods to be adjusted magnetically to reduce the number of invasive surgeries until the spine stops growing.

Spine growth is characterized by synchronized growth that influences standing and sitting height, thoracic cage shape, volume and circumference, and finally, lung development. Measurement of the sitting height provides an indirect reflection of spinal growth and correlates strictly with trunk height.

It occurs in a predetermined pattern of acceleration and deceleration events. Sitting height approximates 66% of the final sitting height from birth to 5 years, growing from 35 to 62 cm. Between 5 and 10 years, it increases by approximately 12 cm, while puberty is characterized by an additional 12 cm. In children with severe spinal deformities, loss of sitting height is related to the severity of the deformation.

Assessment of the T1-S1 segment becomes more relevant since many spinal deformities originate in this segment. The T1-S1 segment grows approximately 10 cm during the first 5 years of age (>2 cm/year), about 5 cm between 5 and 10 years (0.9 cm/year), and approximately 10 cm during puberty (1.8 cm/year). Thus, the TI-S1 segment’s most rapid and greater total growth period occurs before 10 years of age.

As the spinal deformity progresses, it is crucial to understand that the thoracic cage growth is also modified. The thoracic spine provides the vertical component of the thoracic volume, whereas the rib cage contributes to the width and depth.

Thoracic cage volume at birth is approximately 6% of its final size; at age 5, it reaches 30%, and by 10 years, it reaches 50%. At birth, thoracic spine height measures 12 cm; at 5 years, it measures 18 and 27 cm at skeletal maturity

Despite this claim, studies have found that Magec Rods do not eliminate the need for additional surgeries and that the device is linked to numerous alleged product defects and adverse health complications.

What is Metallosis?

Metallosis is a type of metal poisoning that involves the deposition and buildup of metal debris in the body’s soft tissues. The condition is thought to occur when metallic components in medical implants rub against one another over time.

Related Article: Metal-on-Metal Hip Implants Prone to Metallosis

Metallosis Symptoms

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Central nervous system dysfunction
• Heart problems
• Anemia

Can I File a Rod Magec System Rods Lawsuit?

Only a qualified attorney can determine whether you are eligible to file a lawsuit over defective Nuvasive Magec System Devices, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.

Most cases involving medical devices allege that a product was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain complication.

In the case of the Magec Rod, our attorneys suspect that patients may be able to take legal action in light of claims that NuVasive failed to adequately warn doctors and patients about the risk of metallosis and implant failure.

How Can Filing a Nuvasive Magec System Lawsuit Help Me?

By filing a lawsuit against NuVasive, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your injury, as well as for damages for pain and suffering.

Additionally, filing a lawsuit can help hold the manufacturer accountable for releasing an allegedly defective drug into the marketplace, and to discourage other companies from engaging in similar conduct.

FAQs

How can patients determine if their complications are related to MAGEC rods?

Patients can determine if their complications are related to MAGEC rods by consulting with their healthcare provider, reviewing their medical history, and considering whether complications began or worsened after the device was implanted.

Are there any recalls associated with MAGEC rods?

Yes, specific models and lot numbers of MAGEC rods have been involved in recalls due to higher than expected rates of failure and other issues. Patients should check with their healthcare provider and the FDA website for information on recalls related to their specific device.

Can I join a class action lawsuit if I was affected by the MAGEC rod recall?

Yes, individuals affected by the MAGEC rod recall may join a class action lawsuit if one is available. Class action lawsuits allow multiple plaintiffs to combine their cases, providing a stronger collective legal action against the manufacturer.

How long do I have to file a MAGEC rod lawsuit?

The time limit to file a MAGEC rod lawsuit, known as the statute of limitations, varies by state. It’s crucial to consult with a lawyer promptly to ensure your claim is filed within the legal timeframe to preserve your rights.

See all related medical device lawsuits that our lawyers covered so far.

Get a Free Magec Rod Lawsuit Evaluation With Our Lawyers

The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Magec Rod lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Again, if your child had problems after receiving the NuVasive Magec Rod, you should contact Schmidt and Clark’s lawyers immediately for a free legal consultation. You may be entitled to financial compensation by filing a suit and our medical device lawyers can help.

References:

1. https://www.fda.gov/medical-devices/safety-communications/potential-concerns-nuvasive-magec-system-implants-fda-safety-communication
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9458941/