InjuryODU
ENDOTINE
Received Jun 19, 2026 · Event occurred May 22, 2026
Report 2020601-2026-00005 · MDR key 25566462
Device
Generic name
Endotine Forehead 3.0
Manufacturer
Microaire Surgical InstrumentsModel number
CFD-22202Catalog number
CFD-22202
Product problems
- Break
Patient
NA · Unknown
- Inadequate Osseointegration
Narrative
Additional Manufacturer Narrative
DEVICE LOT IS NOT YET DETERMINED. DEVICE IS EXPECTED TO BE RETURNED TO MANUFACTURER, BUT HAS NOT YET BEEN RETURNED FOR FULL EVALUATION AND INVESTIGATION.
Description of Event or Problem
ACCORDING TO THE CUSTOMER THEY TOOK A PATIENT BACK TO SURGERY TO RESUSPEND THE BROW. DURING THE PROCEDURE IT WAS NOTED BY THE PHYSICIAN THAT THE PREVIOUS ENDOTINE HAD BROKEN OFF FROM THE ANCHOR POINT IN THE BONE.