inforMED
MalfunctionEIY

ROOT FILLERS -L-

Received May 4, 2018

Report 9611053-2018-00052 · MDR key 7486767

Device

Generic name

Instrument, Filling, Plastic, Dental

Manufacturer

Dentsply Vdw Gmbh

Model number

NA

Catalog number

V040393025035

Lot number

UNK

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.

Description of Event or Problem

IN THIS EVENT IT WAS REPORTED THAT A PASTE FILLER SEPARATED. THE SEPARATED PIECE WAS RETRIEVED AND TREATMENT WAS 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.