FINISHING DISC RA REFILL
Received Jun 15, 2026
Report 2515379-2026-00095 · MDR key 25500090
Device
Generic name
Agent, Polishing, Abrasive, Oral Cavity
Manufacturer
Dentsply LlcCatalog number
624045
Lot number
00167881
Product problems
- Break
Patient
Not reported
- Insufficient Information
Narrative
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 RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT A FINISHING DISC RA REFILL BROKE OFF CAUSING IT TO BE VERY SHARP AND A BURNING SENSATION. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.