BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROOT FILLERS -L-

    MDR report key: 8024753 · Received October 31, 2018

    Report

    Report Number
    9611053-2018-00174
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Report Date
    December 12, 2018
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EIY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    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 HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A ROOT FILLER BROKE IN A PATIENT'S TOOTH. THE TOOTH WAS FILLED WITH BROKEN PART INCORPORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863026 ROOT FILLERS -L- INSTRUMENT, FILLING, PLASTIC, DENTAL EIY DENTSPLY VDW GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1