The devices, which brace the spines of children with scoliosis, were the subject of recalls in 2020. The company reportedly fixed the previous mechanical issues. However, the FDA has since received complaints about other risks associated with the devices. Although the FDA warning isn’t a mandatory recall, it suggests the issues with MAGEC devices may result in litigation down the line.
What is the MAGEC System?
The MAGEC System is implanted into the patient to brace the spine during growth, minimizing the progression of scoliosis. It is used to treat early-onset scoliosis (in children under age 10), for which nonoperative treatment has failed.
The system works by implanting adjustable growth rods into the patient. Magnets and an external remote control the rods, which straighten the spine as the patient grows. The implants can “loosen, fracture, corrode, migrate, or cause pain.” As such, the rod may continue to lengthen, distract, or serve as an internal brace after the separation of its end cap component. The long-term ability of a rod with a separated end cap to lengthen or distract in a patient is unknown.
Per the recall, 0.5% of devices have had the separation of the rod’s actuator end cap component. This could lead to the degeneration of its internal components. Additionally, it could lead to an “egress of Titanium alloy wear debris and resultant localized tissue discoloration.”
The Recall History
In February 2020, NuVasive issued an Urgent Field Safety Notice voluntarily recalling its MAGEC System Model X rods. The notice recommended that healthcare providers examine their inventory. Furthermore, healthcare providers should quarantine affected products while ceasing implantation of Model X rods until further notice. For patients who had already undergone implantation, the notice recommended that patients follow appropriate postoperative procedures. Patients should also assess the device via X-ray imaging whenever a physician adjusts it or at minimum, every six months. If the rod’s end cap has separated from the actuator, the notice states the treating physician should determine whether to remove the device. If removed, the physician should ensure all components of the rod remains intact. The physician should also make sure to remove all device accessories.
In July 2020, the FDA approved the MAGEC Model X rod’s modified version, “designed to mitigate endcap separation events.” However, by December 2020, NuVasive issued an updated Field Safety Notice. The notice indicated the MAGEC System could experience “locking pin breakage, O-ring seal failure, generation of metal wear debris, and failure of the rod to distract.” Patients also experienced localized tissue discoloration from the rod as well as metal allergies and sensitivities. The notice, which affected patients in the European Union, did not recommend a prophylactic removal of the rod. Furthermore, it stated that the notice was not “a new or enhanced safety issue.” However, physicians and patients were encouraged to consider the use of the MAGEC system in the European Union only in essential cases until further notice.
By April 2021, NuVasive notified healthcare providers of biocompatibility concerns of its components. The company voluntarily placed a global shipping hold on all MAGEC devices.
The FDA’s Warning
In 2021, the FDA received complaints of local tissue reactions potentially related to MAGEC endcap separation. As the FDA explained, endcap separation results in unanticipated exposure of a patient’s tissue with internal components of the device. As such, these components must be tested for biocompatibility.
In July 2021, the FDA issued a warning concerning MAGEC’s mechanical failures. The warning also addressed subsequent tissue incompatibility that can occur upon exposure to these components. The FDA stated that NuVasive is continuing to investigate these issues. NuVasive will also evaluate new testing results to determine the impact, if any, this concern may have on patients. At this time, the FDA has not recommended the removal of any device. Around the same time of the FDA’s notice, NuVasive lifted its shipping hold.
The warning covers several products including NuVasive’s MAGEC system and MAGEC System Model X devices. The warning also encompasses:
- MAGEC System Model X Rods
- MAGEC System Rods
- MAGEC Spinal Bracing and Distraction System
- MAGEC 2 Spinal Bracing and Distraction System
Potential NuVasive’s MAGEC Lawsuits
In general, surgically implanted defective medical devices can pose a significant danger to patients. Because of their innate invasiveness, those devices also have a heightened potential for litigation. In the case of the MAGEC systems, endcap separation can result in exposures that could prompt various allergies and adverse reactions. While the biocompatibility of these components is still unknown, the complaints already received about skin discoloration are concerning.
Aside from adverse reactions related to component exposure, the long-term efficacy of the device itself, when broken, remains unknown. There is little information as of now as to how the endcap components affect the rod movement long-term. Nevertheless, it is reasonable to assume that such defect may lead to broken rods and subsequent device failure. Furthermore, the defect could lead to the potential need for additional surgeries. Most notably, the affected patients are all under 10 years old. If such defects render permanent injuries, the damages can be substantial.
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