MalfunctionODU
ENDOTINE FOREHEAD 3.5
Received May 27, 2026 · Event occurred Mar 6, 2026
Report 2020601-2026-00004 · MDR key 25304420
Device
Generic name
Endotine Forehead 3.5
Manufacturer
Microaire Surgical InstrumentsModel number
CFD-22102Catalog number
CFD-22102
Lot number
437425
Product problems
- Fracture
Patient
63 YR · Male
- Inadequate Osseointegration
Narrative
Description of Event or Problem
CUSTOMER STATES RIGHT BROW DROPPED SEVERAL DAYS AFTER SURGERY ON (B)(6) 2026. A SECOND SURGERY TO REPLACE ENDOTINE WAS DONE ON (B)(6) 2026.