PROFILE ORIFICE OPENER FILES
Received Jun 29, 2006
Report 2320721-2006-00276 · MDR key 734333
Device
Product problems
- Device, or device fragments remain in patient
- Material Separation
Patient
30 YR
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
IT WAS REPORTED THAT TWO FILES FROM THE SAME LOT SEPARATED ON THE SAME PATIENT. THE ROOT CANAL THERAPY WAS COMPLETED BY INCORPORATING THE SEPARATED PIECES INTO THE FILL.
Additional Manufacturer Narrative
IN THIS INCIDENT THERE WAS NO REPORT OF INJURY TO THE PATIENT. HOWEVER, AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS (THOUGH INADVISABLE PER EXPERT OPINION PROVIDED BY DR.) TO PRECLUDE INJURY OR ILLNESS THAT WOULD NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS RETURNED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE. TWO LOT NUMBERS WERE PROVIDED BY THE INITIAL REPORTER: 033006251 (MANUFACTUER 03/30/2006) AND 010406215 (MANUFACTURED 01/04/2006). IT IS UNK WHICH, IF EITHER, WAS INVOLVED IN THE EVENT.