ROOT FILLER -L-, STERILE
Received Nov 29, 2020
Report 9611053-2020-00367 · MDR key 10916508
Device
Generic name
Instrument, Filling, Plastic, Dental
Manufacturer
Dentsply Vdw GmbhModel number
NACatalog number
V040393025030
Lot number
264710
Product problems
- Break
- Material Separation
- Break
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE INVOLVED PASTE FILLERS THAT HAVE BROKEN DURING USE HAVE NOT BEEN RETURNED AND CANNOT BE ANALYZED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1455636, #1478554 AND #1477871). THE UNUSED PASTE FILLERS 25MM N°2 RETURNED HAVE BEEN MEASURED AND HAVE BEEN FOUND IN COMPLIANCE WITH SPECIFICATIONS. FOR INFORMATION, NO MECHANICAL TEST IS APPLICABLE REGARDING THIS PRODUCT. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PATIENT OUTCOME.
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 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 WAS REPORTED THAT PASTE FILLERS OF A CERTAIN LOT ARE SEPARATING. NO INJURY REPORTED. THE OUTCOME OF THE EVENT IS UNKNOWN AS OF THIS MDR EVALUATION.