Free Confidential Lawsuit Evaluation: If your child or other loved one suffered complications from scoliosis surgery, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: FDA Warns of Mechanical Failures, Tissue Incompatibility in Growing Spinal Rod System
The U.S. Food and Drug Administration (FDA) on July 15, 2021, released a safety communication regarding potential mechanical failures and concerns of tissue incompatibility associated with components from a growing spinal rod system from NuVasive Specialized Orthopedics. The devices reported by the FDA include the:
- 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
NuVasive recalled its Magec devices in February 2020 to address a mechanical component failure where the endcap was separating from the rod part of the device. FDA in July 2020 approved the modified version of the Magec Model X rod, designed to mitigate endcap separation events.
In early 2021, FDA began receiving reports that described local tissue reactions potentially related to endcap separation event with the Magec devices, according to the release. NuVasive voluntarily placed a global ship hold on all Magec devices in April 2021 due to these biocompatibility testing concerns, which was lifted on July 15, 2021.
What’s the problem?
Our lawyers have been contacted by consumers alleging that the NuVasive Magec System, a radical new treatment for children who were diagnosed with early-onset scoliosis, alleging that the device caused metallosis — condition involving deposition and build-up of metal debris in the soft tissues of the body — and premature implant failure, complications that require the need for extensive additional surgeries to correct the problem.
How Do Magec Rods Work?
Growing rods are attached on both sides of the spine to correct the abnormal curvature of scoliosis. It’s an effective treatment, but also requires repeated invasive surgical lengthening under general anesthesia,” according to researchers at the University of Minnesota.
Since EOS is only diagnosed in children under the age of 10, patients continue to develop physically after their first set of growing rods are implanted. To account for these normal changes in growth, and reduce the risk that the spine’s curvature will affect lung and/or heart growth, surgeons must replace the patient’s growing rods with a larger set periodically.
Traditional Growing Rods Vs. NuVasive Magec System
When braces, casts and other orthotic devices are not sufficient to control the severe spinal curvature of early-onset scoliosis, most surgeons turn to growing rods, which are surgical implants that guide the spine’s development as a child ages.
The problem is that as the spine grows, the rods need to be lengthened quite frequently, as often as every 6 months, according to the Columbia University Medical Center (CUMC). Traditional growing rods cannot simply be extended inside a patient’s body. Instead, surgeons must perform another extremely invasive procedure, removing the old implants and replacing them with longer ones.
Magec Rod Complications
- Skin discoloration
- Metallosis
- Failure of the rods to distract (lengthen) when required
- Bent or broken rods
- Implant failure
- The need for painful revision surgery
Facts About Scoliosis
Scoliosis is a condition in which the spine curves sideways, according to the Mayo Clinic. All spines are at least a little curved – a normal human backbone is an “S”-shaped structure with 4 distinct curves. However, if the angle of any of these curves measures 10 degrees or more, this constitutes a diagnosis of scoliosis.
Symptoms of Scoliosis
- Visibly curved spine
- Leaning to one side
- Uneven shoulders
- One shoulder / hip sticking out
- Ribs sticking out on one side
- Clothes not fitting well
How Many Surgeries Do Scoliosis Patients Have?
Most kids must have surgery every 6 to 8 months, with some requiring up to 20 procedures before treatment is complete, according to Boston Children’s Hospital. And after the growing rods have finally been removed, many children will have to face an additional spinal fusion surgery.
Why Our Law Firm Is Filing Individual Lawsuits Opposed To a Class Action
In cases of complex product liability litigation, class action lawsuits can be a bad choice for many plaintiffs, as they often result in “low ball” settlements and higher attorneys fees. At Schmidt & Clark, LLP we understand that our clients are suffering emotionally and economically due to loss of wages and/or high medical bills and we plan to maximize each client’s recovery by filing individual Magec Rod lawsuits on their behalf.
Do I Have Magec Rod Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in NuVasive Magec Rod lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if your child had problems after receiving the NuVasive Magec Rod, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.