Mother of child with spinal rod has ‘handed over trust’ to surgeon

A Mayo mother whose child received a spinal implant that became subject to a product recall has said she has "handed over my trust" to her daughter's surgeon and will leave it in place with ongoing monitoring.

Last week it emerged that some titanium Magec Model X rods, used in small children with severe scoliosis, were found to be defective.

The American manufacturer, NuVasive, said any decision to remove devices already implanted in children was up to surgeons and the families affected.

Children's Health Ireland, which runs the country's main paediatric hospitals, later concluded a review of an unspecified number of cases in Ireland that it said had identified no faults.

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Paula Jordan's eight-year-old daughter, Aideen Burke, had one of the devices fitted in 2018. Ms Jordan said although it had "crossed her mind" to have the rod removed after the recall was issued, she has confidence in her daughter's surgeon and treatment.

“I was reassured by my conversation with him, and then they rang me again [the following day],” she said.

“But then I began thinking, you know, if it was your toaster or your kettle, you would be sending it back. But this isn’t, this is my daughter.”

However, Ms Jordan said Aideen has been doing well physically since receiving the implant, and that if the problems identified with the rods were very serious, the manufacturer would have advised immediate removal.

“I have handed over my trust because it’s not in my area [of expertise],” she said of the surgeon, and explained that the situation would be monitored via regular check-ups.

“To the trained eye it’s very obvious if this component is coming off, and they will check every time she is X-rayed.”

Potential problems

It is understood 31 Magec rods covered by the recall notice were in Ireland but it is not clear how many were implanted in children.

A medical source said concerns must remain around the potential for problems to arise at a later stage.

Children’s Health Ireland said it “acknowledges that there can be complications with any implant. If this happens with any of the Magec rods, the complications will be dealt with appropriately”.

The recall was issued when it was found that an end-cap in some of the rods had separated, a flaw that could expose internal components including titanium alloy debris.

A review of Irish cases found this separation had not happened in Ireland but the issue had raised concerns within the medical community, where views of the Magec system were known to vary.

Regarding the next steps by medical staff, Children’s Health Ireland said “following the agreed treatment plan, all children will continue to be monitored and assessed both clinically and with X-rays at regular intervals”.