NuVasive Magec (implants for the treatment of scoliosis)

2020: Withdrawal of defective implants for the treatment of scoliosis

In mid-December 2020, NuVasive issued a voluntary notification of problems regarding defective implants for the treatment of Magec scoliosis. Defective products break and bring patients severe pain.

The Magec system is a metal spinal implant designed to fix the spine during growth. It is assumed to minimize progression of scoliosis in children and adolescents. Instructions for using the device indicate that in some cases implants can loosen, break, corrode, move or cause pain.

NuVasive reported the recall of defective implants for the treatment of scoliosis, which break and bring pain

In March 2020, NuVasive urgently notified doctors and users of a potential safety problem. It turned out that under certain conditions, some components can involuntarily separate from the rods of Model X of the Magec system. The notice dated December 7, 2020 was an addendum to the original notice published in February 2020.

According to the manufacturer, problems with implants can occur naturally in the form of breakage of the locking pin, depressurization of the sealing ring, wear and tear of the metal or release of the rod. In addition, when using the Magec rod, a local change in the color of the tissues can be noted.

Affected patients may require surgery to remove/revise the implant, the company said. Patients who considered implanting a Magec rod or rods are advised not to rush and wait for a full test. However, NuVasive does not recommend preventive removal of the functioning rod.

By mid-December 2020, Magec retains the CE certificate, but the notified DQS authority Medizinprodukte GmbH has already begun checking the system.^[1]

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