You’re not alone. The NuVasive MAGEC System is a type of spinal implant that promises to straighten the spine in children with this condition. However, many children suffered injuries, including from rod fractures, failure of the device, and additional surgeries that could lead to complications.
Join the Many is working to educate and support victims who have been harmed by these devices.
What Is the NuVasive MAGEC System?
The NuVasive MAGEC System is a device designed to help children in the early stages of scoliosis. It worked using a magnetic rod that was implanted into the body. An external remote controller was then used to control the rods, allowing them to have adjustments made over time and working to slowly improve the curve of the spine.
Seattle’s Children’s Hospital described these magnetic rods as “growing rods” that were placed into the spine and could expand over time, helping to straighten out the spine overall. For some patients, this type of device is incredibly valuable, working to enable children who otherwise could not walk or may suffer a shortened life expectancy as a result of their condition to see significant improvement.
The use of rods is not necessarily new because doctors have been using tools like this for a long time to help with the straightening of the spine. What is different is the way the NuVasive MAGEC System works. Instead of having to perform a surgical procedure often on the patient to extend the rods, this device works magnetically. With the push of a button, the device can be expanded. There’s supposed to be no pain and a simple “less than one hour” treatment time instead of days spent in the hospital after surgery and all of the risks that come with it.
The device is used in a range of situations. Specifically, it is used for those who have early onset scoliosis with significant symptoms.
The system offers lots of promised benefits, such as a new solution that would eliminate the need for spinal fusion or the need to have surgical procedures over 6 to 12 months.
What Are the Problems Associated with the NuVasive MAGEC System?
Both caregivers and patients have come forward with a number of alarming concerns related to the NuVasive MAGEC System. These individuals have suffered a number of complications related to the use of the device.
One of the most common claims is that the endcaps on the rods can come off. They can detach from the position they are supposed to remain in, causing significant pain and suffering when they do.
Some of the most notable complications of the NuVasive MAGEC System include:
- Rods that break
- Fixation failures
- Screw blockage
- Metal particles break down from wear and tear
- Fractures of the drive pin
- Infection
- Tissue death
- Autofusion of the spine
- Spinal deformities
- Cancer
- Metallosis
For some people, the device has caused a significant amount of pain, while for others, it has created an inflammation risk that has led to serious and life-threatening infections. This is often from metal particles that are released into the surrounding tissues, causing a reaction in the body.
A number of studies have been done to gain more insight into what is occurring with the device. In a study released in 2019 and published in the National Library of Medicine, it found that, overall, 48% of patients who used the NuVasive MAGEC System saw complications with the device. In addition, 44% of those individuals also suffered additional, unplanned surgeries as a result of those complications. This study, which was done over a 2-year period, was comprehensive. With nearly half of all people having complications from the procedure, it is a very alarming indication of the problem with the NuVasive MAGEC System.
Has NuVasive MAGEC System Been Recalled?
In July 2021, the U.S. Food and Drug Administration (FDA) took action to inform patients as well as caregivers, and healthcare professionals of the numerous risks associated with the use of this system. The FDA stated that there was the potential for mechanical failures related to the device and that there are tissue-related incompatibility concerns.
The FDA notice included various components of the NuVasive Specialized Orthopedics’ MAGEC devices, including:
- 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
In February 2020, NuVasive released an Urgent Field Safety Notice. This led to the recalling of the device. The company recalled it to address the mechanical component failure that was occurring on the endcap that caused it to separate from the rod itself.
Then, in July 2020, the FDA approved the use of a modified version of the device, called the MAGEC Model X rod. This redesigned the endcap to prevent further problems.
However, this was not the end of the problems with the device.
The FDA learned of biocompatibility concerns with the existing endcap failures in December 2020. At that point, the manufacturer released a Field Safety Notice to the patients using its product in the European Union.
In early 2021, the FDA began receiving reports from patients and healthcare providers about local tissue reactions that are related to the endcap separation events with the devices.
In December of 2021, NuVasive issued another Field Safety Notice for its product to healthcare providers using it in the U.S. It provided more information about the proper use of the product.
The FDA took steps to help providers and patients determine the best treatment option. They stated the device offers numerous benefits and did not remove it from the market. However, it warned of potentially known risks associated with it.
For those who have the device, the FDA did not recommend its removal if it had been functioning properly. However, if patients experience unexpected back pain with the device, additional testing, including x-rays, should be done to evaluate the situation.
These devices are only allowed to be used for a period of two years. They are also only to be used in skeletally immature patients that are 10 years of age or less and who have severe and progressive spinal deformities that have a high risk of Thoracic Insufficiency Syndrome.
Lawsuit History for NuVasive MAGEC System
Many people with the NuVasive MAGEC System have taken legal steps after watching their loved ones struggle with the use of this device. If you are one of the many people facing this hardship, Join the Many can help you stand up to NuVasive makers.
If you have:
- Had the NuVasive MAGEC System implanted prior to the age of 10
- The device was implanted on or after September 1, 2014
- Suffered complications related to the function of the device not otherwise expected
- Or you are the caregiver of a minor who was harmed
Are There Active Lawsuits for NuVasive MAGEC System?
The NuVasive MAGEC System is at the center of a number of lawsuits throughout the U.S. However, these cases are just at the beginning of the process. Thanks to the recall of the device in 2021, it is expected that many additional concerns will arise and more people will come forward.
At this point, many of the cases brought against the manufacturer NuVasive have not yet come to court. That means that they are being researched and developed – and it could take another year or more to see significant action.
If there are new claims against the manufacturer, it is likely that the U.S. Judicial Panel for Multidistrict Litigation will become involved and determine if it is beneficial to consolidate these cases. This has not happened yet with the NuVasive MAGEC System.
People are filing lawsuits as a result of the following:
- Tissue-related problems, including infections and inflammation
- Pain
- Bone abnormalities
- Tissue death
- Cancer
- Metallosis
If you have suffered these or other types of complications, you may wish to take legal action as well. Join the Many is working with others facing these same types of losses, often those who have medical bills, struggled with complications from secondary surgeries, and individuals with deformities.
Have There Been Any Settlements from the NuVasive MAGEC System Lawsuits?
Many of the lawsuits against NuVasive are still very young, and there have been no known settlements in these claims. It could take some time for this information to become available, and in some cases, it may remain confidential.
There have been no rulings in favor of or against the use of the NuVasive MAGEC System. Cases continue to be pending.
How You Can Get Help for Your Losses from the NuVasive MAGEC System
If you have suffered any type of losses from the use of the NuVasive MAGEC System, or your child has done so, and you are their caregiver, you can take action.
- Contact your doctor to report any type of complications experienced. This includes any type of onset of pain or discomfort. Document what’s occurred.
- Reach out to the FDA to report your claim – the FDA is continuing its investigation into these products and may be able to provide you with more up to date information about your risks.
- Turn to an attorney. Do not continue to suffer, and believe there’s nothing you can do. After your free case review with Join the Many, we can connect you directly with trusted firms who are working these cases.
The key to remember here is that the claims being made against NuVasive MAGEC System are very new. There are numerous lawsuits pending, and there are expectations of many more being added in the coming months and years.
How Join the Many Can Help You
We’ll help you determine if you have a case against NuVasive makers. When you decide to take legal action, we’ll support you every step of the way and guide you through the process. We’ll even personally match you with the best legal care available for your case. You’ll pay no legal fees unless you’re awarded compensation.
