ROOT FILLERS -L-
Received Oct 31, 2018
Report 9611053-2018-00174 · MDR key 8024753
Device
Generic name
Instrument, Filling, Plastic, Dental
Manufacturer
Dentsply Vdw GmbhModel number
NACatalog number
V040393025030
Lot number
UNK
Product problems
- Break
Patient
Not reported
- Patient Problem/Medical Problem
- Device Embedded In Tissue or Plaque
- Patient Problem/Medical Problem
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THERE HAS BEEN A PREVIOUS REPORT WITH THE SAME PRODUCT 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
IN THIS EVENT IT WAS REPORTED THAT A ROOT FILLER BROKE IN A PATIENT'S TOOTH. THE TOOTH WAS FILLED WITH BROKEN PART INCORPORATED.
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.