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NuVasive MAGEC


Nationwide Success
Nationwide Success

Medical Device Injury Lawyer

investigating NuVasive MAGEC injury & complications

Some NuVasive MAGEC devices, which brace the spines of children with scoliosis, have been recalled since 2020. NuVasive reportedly fixed the previous mechanical problems but the FDA has still received complaints about other injury risks associated with NuVasive MAGEC devices. The most recent FDA warning isn’t a mandatory recall, though it suggests the issues with MAGEC devices may result in serious injury.

The Lyon Firm litigates medical device injury cases nationwide on behalf of plaintiffs. Following any safety issues with a NuVasive MAGEC device, call for a free case review.

What is the NuVasive MAGEC System?

The NuVasive MAGEC System is a device implanted into a patient to brace the spine during growth. The device is meant to minimize the progression of scoliosis, and treat early-onset scoliosis in children under age 10 when nonoperative treatment has failed.

The NuVasive MAGEC system works by implanting adjustable growth rods into a patient. Magnets and a remote control the rods, which helps straighten the spine as a patient grows. The implants, however, may loosen, fracture, corrode, migrate, or cause serious pain.

NuVasive MAGEC Recalls

As stated in the reason the FDA recall, 0.5% of NuVasive MAGEC devices have experienced a separation of the rod’s actuator end cap components. This separation may lead to the degeneration of its internal components.

In February 2020, NuVasive issued an Urgent Field Safety Notice thereby recalling MAGEC System Model X rods. The safety notice recommended that healthcare providers examine their inventory, quarantine affected products, and cease implantation of Model X rods. For patients who had already undergone NuVasive MAGEC Model X implantation, the company recommended that patients follow appropriate postoperative procedures. Patients should also assess the device via X-ray imaging every six months.

In December 2020, NuVasive issued an updated Field Safety Notice indicating the MAGEC System could experience “locking pin breakage, O-ring seal failure, generation of metal wear debris, and failure of the rod to distract.” Physicians and patients were encouraged to consider the use of the NuVasive MAGEC system in the European Union only.

In April 2021, NuVasive notified healthcare providers of “biocompatibility concerns” of its components. The FDA received complaints of local tissue reactions possibly related to MAGEC endcap separation.

In July 2021, the FDA issued a warning concerning potential NuVasive MAGEC mechanical failures and tissue incompatibility that can occur upon exposure to these components. The warning covered several NuVasive MAGEC system products and MAGEC System Model X devices, including:

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

Defective medical devices can pose a significant safety hazard to patients. Besides adverse reactions related to component exposure, the long-term efficacy of the NuVasive MAGEC device remains unknown. Any defect could lead to the potential need for additional surgeries.

Technological advancements in medical science have delivered hundreds of new medical devices in recent years. When they are necessary for ailing patients, health care providers and patients rely on the judgment, honesty, and skill of medical device manufactures to offer safe products. However, not all of these medical devices have been tested, and many have proved defective, injuring thousands of patients who trusted the companies who marketed the so-called safe products.

Medical Device Defect Lawsuits

Because many of the medical devices on the market may be inadequately tested and rushed to the consumer to make a profit, victims and attorneys have filed many claims against the responsible companies. When manufactures are negligent and injure patients with defective medical devices, litigation is often necessary to restore the financial and human loss that is endured.

Although the U.S. Food and Drug Administration (FDA) is responsible for making sure that medical devices are adequately tested, device recalls have become increasingly common. Device manufacturers are often slow to respond to consumer complaints and must be held responsible for injuries caused.

Defective medical device litigation provides answers when medical device companies are unwilling to be honest with consumers and their physicians about the risks and dangers of their products. 

Many medical device companies have been involved in medical device litigation for defective produce designs and failure to adequately warn claims.  The litigation often precedes a voluntary recall.  Many critics have argued that the lenient FDA 510K process is partly to blame for the increase in medical device defects and injuries reported. 

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ABOUT THE LYON FIRM

Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.

The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.

NO COST UNLESS WE WIN

The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.

Joe Lyon investigates defective medical device products
Helping Families Nationwide

Why is Defective Medical Device Litigation Important?

When defective medical devices injure patients, product liability litigation helps to inform physicians of the true risk of the product, improves patient safety through recalls and design changes, and provides compensation to those injured.  

Medical Device Litigation Informs Physicians

The design defect and failure to warn claims often focus on the company’s lack of testing prior to putting the medical device  on the market market.  Failure to warn claims typically arise from the medical device company failing to adequately warn about the failure or complication rate in the instruction for use that is provided to the physician. 

Many doctors are not fully informed of the risks of the products by corporate sales representatives. Therefore, Medical Device Litigation also informs treating physicians about what the companies knew and tested for regarding the risks of the products. 

When the implanting surgeons are deposed, they are shown corporate documents and studies containing safety information that was never disclosed to them prior to recommending the product to the patient. Often this data includes critical information related to efficacy and higher complication rates with the device.  

Surgeons frequently testify that had they known the adverse safety data, they would not have recommended the device for the patient. 

Medical Device Litigation Leads to Safer Products

Many medical device cases have had a positive impact on public health and safety, and resulted in product design changes, recalls, and enhanced warnings as a result of litigation. In other words, defective medical device lawsuits make products safer so more families do not suffer the same adverse events. 

Medical Device Litigation Provides Compensation

Medical device lawsuits also provide for a sense of justice to the families with compensation and financial security for future medical care and lost income

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FAULTY MEDICAL DEVICES

Learn about Medical Device Approval Processes