BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATES GLIDDEN DRILL

    MDR report key: 3877851 · Received May 15, 2014

    Report

    Report Number
    8031010-2014-00004
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 17, 2014
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    DZA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE INJURY OR ILLNESS THAT WOULD NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THIS EVENT, THEREFORE, 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 · 1

    IN THIS EVENT, IT WAS REPORTED THAT A GATES SEPARATED IN THE CANAL; THE CANAL WAS FILLED WITH THE SEPARATED PIECE IN PLACE WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289966 GATES GLIDDEN DRILL DRILL, DENTAL, INTRAORAL DZA DENTSPLY MAILLEFER 1078384

    Patients

    Seq Age Sex Outcome Treatment
    1