ROOT FILLERS -L-
Received May 7, 2018
Report 9611053-2018-00053 · MDR key 7491913
Device
Generic name
Instrument, Filling, Plastic, Dental
Manufacturer
Dentsply Vdw GmbhModel number
NACatalog number
V040393025035
Lot number
UNK
Product problems
- Break
- Break
- Detachment Of Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
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 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 A PASTE FILLER SEPARATED. THE SEPARATED PIECE WAS RETRIEVED AND TREATMENT CONCLUDED.
Additional Manufacturer Narrative
INVOLVED PASTE FILLER IS ACTUALLY BROKEN AT THE BASE OF THE ACTIVE PART. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NO UNUSED PRODUCT IS AVAILABLE FOR EVALUATION. THE BATCH NUMBER IS UNKNOWN, DHR CANNOT BE REVIEWED. ROOT CAUSES ARE NOT IDENTIFIED. THIS KIND OF EVENT IS TRACKED AND WE MONITOR THE TREND.