RELINE
Received Feb 26, 2026 · Event occurred Feb 4, 2026
Report 2031966-2026-00037 · MDR key 24462118
Device
Product problems
- Material Separation
Patient
NA · Unknown
- Failure of Implant
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT A 6.0 RELINE SET SCREW FAILED WHILE BEING TIGHTENED DURING AN AIS SCOLI FUSION CASE WITH DR. JON ODA. DR. ODA WAS PROVISIONALLY TIGHTENING THE SET SCREW INTO A HOOK AT THE TOP OF THE CONSTRUCT WHEN HE INDICATED IT FELT STRANGE. UPON REMOVAL A LONG THREAD OF METAL HAD SHEARED OFF BUT WAS STILL ATTACHED TO THE SET SCREW. THIS EXTENDED SURGERY BY APPROX. 30 MINUTES AS THE DOCTOR ATTEMPTED TO REDUCE THE ROD TO THE HOOK AGAIN AND INSERT NEW SET SCREW.