Review into surgical rods used in scoliosis patients 'near completion'
Children's Health Ireland has said a review into rods used in some scoliosis patients is "near completion" after criticism from families who said they learned of the product recall through the media.
Claire Cahill off the Scoliosis Advocacy Network said it has been 13 days since the US manufacturer NuVasive issued a product recall notice when it was discovered some of the rods had experienced the separation of an end-cap in the mechanism, potentially exposing some of its internal components, including alloy debris.
“We contacted Simon Harris and Children’s Health Ireland on the day of the notice of the recall," she told RTE's Morning Ireland.
"It is really disappointing to see it first in a newspaper, that parents haven’t been informed properly.”
Children’s Health Ireland said in a statement: "CHI is aware of a field safety notice issued by NuVasive Inc. to inform healthcare providers caring for patients with MAGEC System Model X that there is concern that an end cap component of the rod can become dislodged after it is implanted into a patient. Post-market surveillance data by NuVasive Inc has reported that this has occurred in approximately 0.5% of patients worldwide.
"CHI at Crumlin, where these rods have been part of some patient’s treatment plan, has commenced a review in order to establish if any of the small cohort of scoliosis patients who received MAGEC System Model X Rods since March 2018 were affected. This review is near completion."
It said the parents/guardians of children who have had a Model X rod implanted since March 2018 will receive communication from their consultant orthopaedic surgeon "within the next 24 hours".
"The surgeon will explain the issues to these families and deal with any of their understandable concerns."
It said Crumlin is the only paediatric healthcare provider that uses the MAGEC System Model X Rods adding a dedicated telephone line for parents and guardians with queries in relation to their child’s scoliosis related treatment or surgery is available on 01 409 6877, with the line operating from 9am-12noon, Monday to Friday.
