MalfunctionGZA
PROFILE GT ROTARY INSTRUMENT
Received Mar 25, 2004
Report 2320721-2004-00148 · MDR key 538787
Device
Generic name
Dental File
Manufacturer
Dentsply TulsaModel number
NACatalog number
GTR0402025
Lot number
UNK
Product problems
- Material Separation
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE DOCTOR REPORTED SEPARATING A FILE IN THE PT'S TOOTH DURING A DENTAL PROCEDURE. THE DOCTOR ELECTED TO FILL AROUND THE FILE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PT.