ROOT FILLER L
Received Mar 23, 2018
Report 9611053-2018-00030 · MDR key 7366874
Device
Generic name
Instrument, Filling, Plastic, Dental
Manufacturer
Dentsply Vdw GmbhModel number
NACatalog number
V040393021030
Lot number
103253
Product problems
- Break
- Break
- Material Separation
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. ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN REQUESTED AND WILL BE SUBMITTED AS IT BECOMES AVAILABLE.
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED THAT A PASTE FILLER SEPARATED. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.
Additional Manufacturer Narrative
THE PASTE FILLER RETURNED IN LOOSE IS ACTUALLY BROKEN AT THE BASE OF THE ACTIVE PART. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW. UNUSED INSTRUMENTS WERE MEASURED AND WERE 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. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE BROKEN PIECE WAS EASILY RETRIEVED AND NO INJURY RESULTED.