MalfunctionEMR
PROFILE GT ROTARY INSTRUMENT
Received Mar 10, 2006 · Event occurred Feb 6, 2006
Report 2320721-2006-00089 · MDR key 686168
Device
Generic name
Dental File
Manufacturer
Dentsply TulsaModel number
NACatalog number
GTR0602025
Lot number
102505015
Product problems
- Device, or device fragments remain in patient
- Material Separation
Patient
32 YR
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
A FILE SEPARATED IN THE CANAL DURING A PROCEDURE. THE CANAL WAS FILLED WITH THE SEPARATED PIECE IN PLACE WITHOUT SEQUELA.