BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROOT FILLER L

    MDR report key: 7366872 · Received March 23, 2018

    Report

    Report Number
    9611053-2018-00029
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Report Date
    May 22, 2018
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EIY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PASTE FILLER SEPARATED; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208034 ROOT FILLER L INSTRUMENT, FILLING, PLASTIC, DENTAL EIY DENTSPLY VDW GMBH NA 179031

    Patients

    Seq Age Sex Outcome Treatment
    1