NuVasive has suspended the supply of Magec rods to the U.K. and Ireland while regulators investigate the risk posed by faulty devices used in treating scoliosis.
In a statement Wednesday, the U.K. device regulator said NuVasive had voluntarily taken the action in light of reports of an actuator end cap component separating after implantation.
- NuVasive has previously warned that the problem “could be costly” if the device needs to be redesigned or re-engineered to support its continued use, creating financial headwinds.
NuVasive gained control of the Magec technology in 2016 through its $380 million takeover of Ellipse Technologies. The takeover added a magnetically controlled device for treating scoliosis to NuVasive’s portfolio of spinal surgery technologies.
At the time of the takeover, Ellipse had issued one field safety notice in relation to its Magec devices. More recently, the safety of the devices have come under greater scrutiny, with reports that the rods snap too easily leading some people to question whether the products should have been allowed to come to market on the strength of data from pigs and cadavers.
NuVasive issued its first urgent field safety notice about the Magec rods last year. That safety notice described a problem with Magec devices made prior to March 2015, but since then issues relating to the latest version of the technology, Magec X, have begun to emerge.
In February, NuVasive said postmarket surveillance data showed 0.5% of Magec X devices had been affected by actuator end cap separation. The fault can expose internal parts of the actuator, causing devices to deteriorate faster than expected and tissue to discolor due to titanium alloy wear debris.
The U.K. Medicines and Healthcare products Regulatory Agency issued an alert about the problem last month. MHRA called for the identification and quarantining of all affected devices and additional follow up for patients who have already received Magec X rods to check for end cap separation. The agency wanted all patients to undergo X-ray imaging within three months, but in its latest update it acknowledged that the COVID-19 pandemic may stop that from happening.
In the interim, MHRA has told surgeons not to implant Magec rods. The Republic of Ireland has also taken action. NuVasive said it is working with agencies in both countries as they carry out a market surveillance review of Magec rods.
Europe has been a growth market for NuVasive, with 20% growth in the region in the fourth quarter driving international sales up 14% to $64.1 million. NuVasive does not break its sales down by product or country, making it impossible to gauge the impact of actions taken in the U.K. and Ireland, but the potential fallout from the Magec problems is significant enough to warrant a mention in the company’s risk disclosures.
“If we are unable to resolve the issues identified in the field safety notice, we may need to re-design or re-engineer the MAGEC X rod, which could be costly. Further, if our surgeon customers and their patients choose alternative treatments, it would negatively impact our pediatric business,” NuVasive wrote in its annual report.
NuVasive introduced Magec X for treatment of early onset scoliosis in the U.S. in 2018.