The MAGEC system by NuVasive is an adjustable magnetic rod-based spinal implant system used to treat Early Onset Scoliosis (EOS) in children with reduced surgical procedures. In February 2020, NuVasive acknowledged that 0.5% of the MAGEC systems implanted were degrading.[1]
Degradation of this medical device could lead to various injuries including metallosis – small bits of metal entering the blood – or unanticipated exposure to internal device components with the potential for adverse reactions. Degradation could also result in device failure, such as rods breaking or bending, separation of mechanical parts, or failure during the lengthening process at medical visits.
Health Canada recalled the MAGEC system on February 13, 2020, stating that “post-implantation separation of an actuator end cap component has been observed.” [2] A similar recall was issued by the Federal Drug Agency (FDA) in the United States.[3] In response, NuVasive developed a newer model MAGEC system to address the end cap separation issue. But, during this time, concerns of the harm potentially caused by unanticipated exposure to internal components and their biocompatibility increased.
In April 2021, NuVasive informed health care providers of biocompatibility testing concerns, and voluntarily placed all MAGEC devices on a global shipment hold, including shipments to Canada. In July 2021, the FDA in the United States issued a safety communication, discussing concerns such as unanticipated exposure of patients’ tissue to internal device components, potentially resulting in various allergies and adverse reactions.[4] Health Canada did not provide any such safety warning regarding biocompatibility concerns.
NuVasive is currently testing whether the components covered by the endcap are biocompatible to meet regulatory standards in the United Kingdom and internationally.[5] To the best of our knowledge, testing is ongoing and the shipment hold is still in place for Canada.
In addition to the immediate concerns of adverse reactions and device failures, the long-term component exposure and long-term efficacy of a degraded device is unknown. Defects could lead to additional surgeries with the associated increased infection risk, anesthesia exposure, and anxiety for young children and their families. Furthermore, given the use of this product in children, defects could result in substantial and long-term injuries.
If you are interested in discussing this issue with the class actions department Wagners, please don’t hesitate to contact us at 902-425-7330 or toll-free at 1-800-465-8794 or by email at [email protected].
[1] https://www.nuvasive.com//www/wp-content/uploads/2020/02/Field-Safety-Notice-MAGEC-X.pdf
[2] https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73743r-eng.php
[3] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=85495
[4] https://www.fda.gov/medical-devices/safety-communications/potential-concerns-nuvasive-magec-system-implants-fda-safety-communication
[5] https://www.nuvasive.com//www/wp-content/uploads/2021/04/Company-statement_MAGEC-and-Precice-CE-Mark_09April2021.pdf