MalfunctionEMR
PROFILE GT ROTARY INSTRUMENT
Received Mar 31, 2006 · Event occurred Feb 27, 2006
Report 2320721-2006-00102 · MDR key 694435
Device
Generic name
Dental File
Manufacturer
Dentsply TulsaModel number
NACatalog number
GTR0804025
Lot number
UNK
Product problems
- Device, or device fragments remain in patient
- Material Separation
Patient
42 YR
- Nonresorbable materials, unretrieved in body
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
A FILE SEPERATED IN THE CANAL DURING A PROCEDURE. THE PATIENT WAS REFERRED TO A SPECIALIST FOR FURTHER TREATMENT, THOUGH OUTCOME OF THE EVENT IS NOT KNOWN AS OF THIS REPORT.