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'No adverse events' found after review of children affected by scoliosis implant recall

Yesterday, Children’s Health Ireland said it would contact all parents of children affected by the recall.

File photo. Child with scoliosis.
File photo. Child with scoliosis.
Image: Shutterstock/YAKOBCHUK VIACHESLAV

THE PARENTS OF children with scoliosis have been told there were “no adverse events” – connected to an implant recall – found in any case at Children’s Health Ireland (CHI), the umbrella body for the country’s main paediatric hospitals. 

Thirty-one such devices had been placed on the Irish market, sparking concern among many parents, although it was not immediately clear how many patients here received the implant.

Yesterday, CHI said that parents would be contacted within 24 hours in connection with the type of titanium spinal rod that some children with scoliosis had been implanted with. 

Manufacturer NuVasive issued an “urgent” Field Safety Notice (FSN) earlier this month to inform healthcare providers caring for patients with MAGEC System Model X rods.

The device is made up of two titanium rods that are inserted during spinal surgery on children who have scoliosis (curvature of the spine). The rods have a small magnet that allows the rod to lengthen as the child grows.

In a statement this evening, CHI said it could confirm that it has “completed the review of clinical records and x-ray images of the small cohort of scoliosis patients who received Magec System Model X rod after March 2018 were affected”.

Each of the patients who had one of these models implanted since March 2018 and whose serial number matched the field safety notice issued have now received a telephone call from their consultant orthopaedic surgeon.

This surgeon “explained all the issues involved and dealt with any of their understandable concerns”, according to CHI.

“Each of these patients records have been reviewed and no adverse events or concerns have been identified,” CHI said.

The hospital group added it will continue to monitor all patients undergoing treatment for scoliosis and will act accordingly with any new information in relation to the MAGEC rod system.

Yesterday, Claire Cahill, co-founder of the Scoliosis Advocacy Network, said there has been a lack of communication from CHI to parents about the issue, despite the safety notice being issued almost two weeks ago.

Cahill said many parents may not be aware of the exact model of Magec rod that was implanted in their child and called on CHI to contact parents, letting them know if they are not affected or if a consultation may need to be arranged to check the status of their child’s implant. 

“That’s the most important thing – that children are safe and safeguarded, and that parents are notified in a timely fashion. Open and transparent communication is needed,” Cahill told TheJournal.ie.

Cahill said on Twitter this evening that she would welcome an x-ray and face to face meeting with a spinal team to discuss the field safety notice.

With reporting from Órla Ryan

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Sean Murray

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