inforMED
MalfunctionEIY

ROOT FILLER L

Received Mar 23, 2018

Report 9611053-2018-00029 · MDR key 7366872

Device

Generic name

Instrument, Filling, Plastic, Dental

Manufacturer

Dentsply Vdw Gmbh

Model number

NA

Catalog number

V040393021035

Lot number

179031

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; NO INJURY RESULTED.

Additional Manufacturer Narrative

ONLY UNUSED PASTE FILLERS WERE RETURNED. INVOLVED PRODUCT THAT BROKE DURING USE IS NOT AVAILABLE AND CANNOT BE ANALYZED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR 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.