PROTAPER SHAPING 1 PTURS121
Received Nov 19, 2021 · Event occurred Nov 2, 2021
Report 2320721-2021-00103 · MDR key 12845010
Device
Generic name
Drill, Dental, Intraoral
Manufacturer
Tulsa Dental Products LlcCatalog number
PTURS121
Lot number
1666640
Product problems
- Break
- Separation Problem
- Break
Patient
Unknown
- Device Embedded In Tissue or Plaque
- Insufficient Information
- Device Embedded In Tissue or Plaque
- Insufficient Information
Narrative
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED INDICATING THE BROKEN PORTION OF THE FILE WAS INCORPORATED INTO THE ROOT CANAL FILLING.
Additional Manufacturer Narrative
A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.
Description of Event or Problem
IT WAS REPORTED THAT 4 SEPARATED S-1 FILES IN THE PAST 2 MONTHS REPORTED BY TWO DIFFERENT DOCTORS.
Additional Manufacturer Narrative
AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS 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 NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.