GUTTA-PERCHA PLUGGER
Received Jan 8, 2020
Report 8031010-2019-00287 · MDR key 9566713
Device
Generic name
Plugger, Root Canal, Endodontic
Manufacturer
Dentsply MailleferModel number
NACatalog number
A289S00100200
Lot number
UNK
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, 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.
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED THAT A PLUGGER BROKE DURING USE; NO INJURY RESULTED AND THE SEPARATED PIECE HAS BEEN RETRIEVED.