BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATES GLIDDEN DRILL

    MDR report key: 3961374 · Received May 30, 2014

    Report

    Report Number
    8031010-2014-00005
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 30, 2014
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    DZA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXITS 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 EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A GATES SEPARATED; THE SEPARATED PIECE WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317964 GATES GLIDDEN DRILL DRILL, DENTAL, INTRAORAL DZA DENTSPLY MAILLEFER 0459870

    Patients

    Seq Age Sex Outcome Treatment
    1