NuVasive MAGEC Side Effects

The NuVasive MAGEC rod is a medical device that gradually lengthens the spine without requiring invasive surgery to treat scoliosis — curvature of the spine.

As of November 30, 2024, the U.S. Food and Drug Administration’s (FDA) MAUDE Database shows 1,061 adverse event reports about NuVasive MAGEC devices since the device was introduced in 2017.

Since 2020, NuVasive has ordered recalls for its Model X MAGEC® System rod. Despite this, the FDA cleared a redesigned Model X rod in July 2020, which remains the only MAGEC device available in the U.S. This new design was supposed to mitigate endcap separation issues. However, in November 2022, NuVasive issued a recall of MAGEC 2 (marketed as MAGEC X) devices manufactured from April 2021 through October 2022.

These issues have raised concerns about the safety and reliability of the MAGEC rod compared to traditional growth rods.

Children with scoliosis often require surgery to lengthen their spine and fix its curve. Hospitals used the NuVasive MAGEC rods because growing rods can help reduce the number of surgeries in scoliosis patients and these were thought to be more technologically advanced devices. However, a Spine Surgery and Related Research study conducted in 2019 revealed that many patients had issues with these rods and often needed unexpected revision surgery when the MAGEC rod’s distraction mechanism failed. These surgeries can be invasive and cause more problems like increased pain and longer recovery times.

The researchers looked at databases that pointed to common issues with NuVasive MAGEC rods. Out of 163 issues reported, 129 were because the rods didn’t lengthen properly.

Other issues they found included broken rods and infections, but those issues happened less often.

9, Risk of MAGEC Complications

Children with early-onset scoliosis treated with magnetically controlled growing rods (MCGRs) — such as NuVasive’s MAGEC — face significant risks of complications, according to a 2024 study in The Journal of Clinical Medicine. Researchers found 66% of patients experienced complications, with 26% requiring additional surgical procedures to fix the problems caused by these medical devices.

Medical issues were common, affecting 45% of the children in the study. Those with more severe spinal curves, particularly over 90 degrees, neuromuscular etiology or who are female, or who were younger than six years old were at higher risk.

Despite these challenges, the study’s authors found that the quality of life for these children and their families in general improved after MCGR treatment, especially when the number of overall surgeries for scoliosis was minimized.

Due to safety and regulatory concerns, NuVasive’s MAGEC system has experienced at least two significant recalls and a temporary CE certification suspension.

These issues, ranging from packaging integrity to potential device failure, led to recalls and global shipment holds as the company worked to address risks and ensure patient safety. The defects in the recalled devices opened NuVasive to MAGEC lawsuits.

February 2020 Recall: Actuator End Cap Separation

In February 2020, NuVasive recalled the MAGEC System Model X rods because they found a problem where a part of the rod could come loose after it was put in. This could happen to about 0.5% of the rods.

This could expose some parts of the actuator, hastening the degradation of the actuator. In some instances, this exposure to the titanium caused discoloration of nearby tissue.

Even if the rods still worked effectively after this happened, NuVasive suggests that people who have them get regular check-ups with their doctor. They also recommended that doctors only take the rods out if this separation happened.

April 2021: Temporary CE Certification Suspension

In April 2021, European regulators temporarily suspended NuVasive’s CE certification for MAGEC devices due to evidence gaps identified by regulatory authorities.

CE certification is a regulatory standard that verifies that a product is safe to use and sell in the European Economic Area. The suspension stopped MAGEC device sales in regions that require the CE Mark. At the same time, the company voluntarily halted shipments globally.

NuVasive assured regulators that it was working to address the certification issues. The company did not recommend removing functioning devices.

November 2022 Recall: Packaging Integrity Issue

In November 2022, NuVasive recalled some MAGEC 2 devices, also known as MAGEC X, because of a problem with how they were packaged.

The company found that 3.8% of the affected units had an issue that interfered with the packaging closure. This could have affected how sterile the devices were.

The company issued the recall to ensure that it was safe and that patients were not at risk. They mentioned that no infections or negative reactions have been reported because of this issue. The affected products were taken back, and doctors didn’t need to do anything extra to monitor the patients who had these devices, according to NuVasive.

In 2021, the FDA issued a safety warning regarding NuVasive’s MAGEC spinal rod system, highlighting potential risks such as mechanical failures, including endcap separation and tissue reactions.

These issues raised concerns about the biocompatibility of the device’s components, especially in children under 10, who rely on MAGEC to avoid multiple surgeries while treating scoliosis. Despite a recall and modifications, the FDA continues to monitor the situation to ensure patient safety.