3M¿ VICTORY SERIES¿ BUCCAL TUBE
Received Jan 14, 2025 · Event occurred Jun 17, 2024
Report 2020467-2025-00001 · MDR key 21152307
Device
Generic name
Tube, Orthodontic
Manufacturer
3m Unitek CorporationModel number
068-914Catalog number
068-914
Lot number
NI
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
38 YR · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND THE LOT NUMBER WAS NOT PROVIDED. A PHOTO OF THE BROKEN BUCCAL WAS REVIEWED; HOWEVER, CAUSE OF THE EVENT COULD NOT BE DETERMINED. SOLVENTUM WILL CONTINUE TO MONITOR.
Description of Event or Problem
IT WAS REPORTED THAT A CYLINDRICAL PART OF A 3M¿ VICTORY SERIES¿ BUCCAL TUBE CAME/BROKE OFF DURING SURGERY. IT REMAINED IN THE WOUND THAT WAS SUTURED. AN X-RAY REVEALED THAT A PIECE OF METAL WAS STILL INSIDE, AND A SECOND PROCEDURE WAS REQUIRED TO REMOVE. THE APPLIANCE TYPE USED IN THE HEADGEAR TUBE WAS NOT SPECIFIED.