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NuVasive MAGEC System Defective Device Drug Lawsuit Source

NuVasive MAGEC System Lawsuits: Magnetic Controlled Growing Rod Systems

Commonly asked questions about the NuVasive MAGEC System:

What is the NuVasive MAGEC System?

The MAGEC System is a magnetic controlled growing rod system that is used to treat Early Onset Scoliosis (EOS) in children. It is manufactured by NuVasive, Inc.

The MAGEC System includes a titanium adjustable growing rod that is surgically implanted and can thereafter be distracted, or lengthened, externally as the child grows. The magnets within the growing rod are controlled by magnets in an External Remote Controller, which allows the physician to control how the rod is lengthened.

NuVasive advertises the MAGEC System as an innovative solution to the challenges of treating EOS. Traditionally, treatment for EOS included growing rods that required additional surgeries to be distracted. These surgeries could be as often as every 6 months.

NuVasive touts the MAGEC System as an alternative to constant surgery. For patients and families, this means minimized risk of infection from open surgical sites, less anxiety and hospital time, reduced medical bills, and less anesthesia exposure to a child’s still developing brain.

However, there have recently been several reports of the MAGEC System failing in various ways, causing children to undergo the additional surgery NuVasive promised would be avoided.

What is Early Onset Scoliosis?

Early Onset Scoliosis is scoliosis that is diagnosed before the age of 10. Scoliosis is an abnormal sideways curvature of the spine.

The distinction between scoliosis and EOS is made because before the age of 10, the spine is still growing, and therefore the treatment must be very different for these young patients.

There are four main causes for EOS:

  • Idiopathic – Curvature for which there is no apparent cause
  • Congenital – Vertebrae develop incorrectly inutero. Sometimes associated with cardiac and renal abnormalities.
  • Neuromuscular – Occurs in the presence of neuromuscular disorders such as spinal muscular atrophy, cerebral palsy, spina bifida, and brain or spinal cord injury.
  • Syndromic – Associated with syndromes such as Marfans, Ehlers-Danlos, and other connective tissue disorders. Neurofibromatosis, Prader-Willi, and many bone dysplasias may be associated as well.

If EOS is not treated promptly and progresses to a severe state, the spine curvature can begin to crowd the space within the chest cavity. This can lead to Thoracic Insufficiency Syndrome (TIS), which occurs when the chest cavity cannot support normal breathing or lung growth.

How Does the NuVasive MAGEC System Treat Scoliosis?

The MAGEC System includes a titanium adjustable growing rod that is surgically implanted and secured using spinal fixation components, including pedicle screws, hooks, and other connectors.

The rod braces the spine during growth to minimize the progression of scoliosis. There is a magnet within the rod that allows it to be adjusted by an External Remote Controller (ERC).

When it is time for the rod to be distracted, the ERC is held over the child’s spine and the magnets cause a magnet in the rod to rotate. The doctor can then control the length of the rod externally.

These noninvasive distractions are meant to be quick and painless, and per the doctor’s instructions, the child can often return to normal activity immediately.

What are the Defects of the NuVasive MAGEC System?

Recently, there have been many reports of failing MAGEC Systems causing dangerous complications in young patients. Studies are now being conducted to determine the long-term effects on these patients as they mature.

The studies are looking at cases where the patient had to undergo unplanned revision surgery, as well as situations where the MAGEC rods were explanted due to serious complications.

These complications include:

  • Failure of the rod to lengthen
  • Rod fracture
  • Drive pin fracture
  • O-ring seal failure
  • Anchor failure
  • Metallosis

A study conducted by the British Scoliosis Society found that 43 out of 195 patients (22%) required unplanned revision surgery. Another study done by International Journal for the Study of the Spine found that out of all available data, rod failure as a cause for revision surgery has been reported in as many as 38% of cases.

What is Metallosis?

Metallosis is one of the more troubling complications of NuVasive MAGEC Systems due to its high prevalence and the unknown nature of long-term side effects.

When there is metal-on-metal contact within a device, the friction can shed metal particles into the body. This causes metal poisoning, or metallosis, which can lead to bone and tissue death, severe pain, and failure of the medical device.

Metal-on-metal contact can occur with MAGEC System rods as distraction occurs. The study conducted by International Journal for the Study of the Spine found that the diameters of the extending bars were reduced in most cases. In some cases, the reduction was so substantial that it could be seen by the naked eye.

In the same study, out of the 34 cases of MAGEC rod explants, all 34 had significant titanium debris inside. Coupled with the frequent failure of the O-ring seal, that debris was likely to escape from inside  the rod and enter the surrounding tissues, thus causing metallosis.

Typically, the common symptoms associated with metallosis include:

  • Visual impairment
  • Auditory impairment
  • Cognitive impairment
  • Nerve problems
  • Heart failure
  • Thyroid problems
  • Skin rashes
  • Infection
  • Loosening or failure of the medical device

However, the long-term effects of high levels of metal ions in children is still unknown. Most studies on metallosis focus on cobalt-chromium ions in adults, but there is little information on the effects of titanium in young children.

There is some evidence suggesting that titanium wear from joint replacements can induce aneuploidy in vitro and in vivo. Recently, links to heart failure have also been reported.

Treatment After NuVasive MAGEC System Complications

Many children who experience complications with their NuVasive MAGEC Systems have to undergo either revision surgery to repair the problem, or extraction surgery to remove the device altogether.

These unplanned surgeries discredit NuVasive’s claims that the device is cost-effective and non-intrusive. Children are exposed to increased risk of infection, as well as the unknown risk of increased exposure to anesthesia at a young age. Because the surgeries are unplanned, the financial and emotional stress is heightened for the patient and family.

Was the NuVasive MAGEC System Approved by the FDA?

NuVasive, Inc. recently announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MAGEC System.

510(k) clearance means that the device simply needs to have a similar intended use and be at least as safe and effective as a device already on the market. In other words, the technological characteristics must be the same as the predicate device, or if different, must not raise new questions of safety and effectiveness.

The FDA determined that the NuVasive MAGEC System was substantially equivalent to the Harrington rod system, which was developed in the 1950s.

This approval system relies on post-market surveillance to detect issues and defects, rather than preemptive testing.

Have NuVasive MAGEC System Lawsuits Been Filed?

As more patients are treated for EOS with the MAGEC System and more reports of complications are filed, NuVasive will be facing legal trouble.

As the manufacturer of the device, NuVasive has a responsibility to its clients and patients. It is the company’s duty to ensure that its products are safe and they perform as designed.

If a patient is injured due to an undocumented complication or device failure, they have a right to seek compensation for their pain and financial losses.

What are the Criteria for Filing a NuVasive MAGEC System Lawsuit?

If your child received a MAGEC System implant and later had to undergo revision surgery, you may be entitled to compensation from NuVasive.

Revision surgery could be necessary if the rod fractures, bends, or fails to distract. In some cases, the device may have to be extracted completely.

If your child develops metallosis from the device, they may have long-term side effects that will require treatment.

In these cases, you and your child could recover compensation for the cost of revision surgery, additional medical treatment, pain and suffering, and more.

Can I File a NuVasive MAGEC System Lawsuit?

Our dangerous device attorneys can help you if your child was harmed by a NuVasive MAGEC System.

We have the experience necessary to take on powerful manufacturers like NuVasive. Our top-rated lawyers are handling litigation nationwide and are currently accepting new MAGEC System cases in all 50 states.

We do not charge any legal fees unless you receive a settlement, and we pay all of the case costs. When we take on a case, we handle it from start to finish so that you can focus on healing.

Our No-Fee Promise on NuVasive MAGEC System Cases

You can afford to have our great team of lawyers on your side. When you choose us, it literally costs nothing to get started.

We promise you in writing:

  • No money to get started
  • We pay all case costs and expenses
  • No legal fees whatsoever unless you receive a settlement
  • Phone calls to our office are always free

How Do I Start a NuVasive MAGEC System Claim?

Our MAGEC System lawyers will help you file your lawsuit. To get started, you can:

  1. Submit the Free Case Review Box on this page, or
  2. Call (866) 280-3417 any time of day to tell us about your case.

We will listen to your story and answer your questions. If you have claim, we will start immediately.

WARNING: There are strict time deadlines for filing NuVasive MAGEC System lawsuit claims.

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