BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICORE DRILL SIZE 31 REFILL

    MDR report key: 7139675 · Received December 21, 2017

    Report

    Report Number
    1718912-2017-00040
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    February 11, 2015
    Report Date
    December 21, 2017
    Manufacturer
    ULTRADENT PRODUCTS INC.
    Product Code
    EJL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY IN THIS EVENT, THERE HAVE BEEN PREVIOUSLY REPORTED EVENTS INVOLVING A SIMILAR DEVICE THAT RESULTED IN THE NEED FOR MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. AFTER EVALUATION OF RETURNED DRILL IT WAS DETERMINED THAT THE DRILL HAD PREVIOUSLY BEEN DAMAGED BY BEING GRASPED TIGHTLY ON THE CUTTING EDGE BY A DEVICE WHICH MAY HAVE BEEN USED TO INSERT THE DRILL INTO THE HAND PIECE. REFILE DUE TO ISSUES WITH UPLOADING TO MAUDE DATA BASE

    Description of Event or Problem · 1

    DENTIST HAD A #1 UNICORE DRILL BREAK IN THE CANAL HE WAS ABLE TO RETRIEVE THE BROKEN PORTION OF THE DRILL FROM THE TOOTH AND PROCEED WITH PROCEDURE. DENTIST REPORTED ALL IS FINE WITH THE TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916785 UNICORE DRILL SIZE 31 REFILL UNICORE DRILL EJL ULTRADENT PRODUCTS INC. B8NYL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other