PROTAPER SHAPING 2 PTURS225
Received Dec 2, 2021 · Event occurred Nov 9, 2021
Report 2320721-2021-00106 · MDR key 12916679
Device
Generic name
Drill, Dental, Intraoral
Manufacturer
Tulsa Dental Products LlcCatalog number
PTURS225
Lot number
UNAVAILABLE
Product problems
- Break
- Entrapment of Device
Patient
Unknown
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.
Additional Manufacturer Narrative
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT PROTAPER SHAPING BROKE IN A PATIENT'S TOOTH. WAS NOT ABLE TO REMOVE AND WAS LEFT AS PART OF THE FILL. NO PATIENT INJURY. WILL BE RETURNING REMAINING FILE.