GUTTA-SMART CONFORM FIT GP CRTG 23G
Received Apr 18, 2025 · Event occurred Apr 16, 2025
Report 2320721-2025-00061 · MDR key 21864285
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- Tooth Fracture
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
NO PRODUCT BEING RETURNED FOR INVESTIGATION. CUSTOMER DISCARDED PRODUCT. NO LOT NUMBER PROVIDED.
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT GUTTA-SMART CONFORM FIT GP CRTG 23G IS SAID TO EXPLODED IN FLOW HANDPIECE AND IN PATIENT'S TOOTH #46. THIS FRACTURED THE TOOTH. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR.
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 WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.