BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INSTRUMENT

    MDR report key: 1171997 · Received September 22, 2008

    Report

    Report Number
    MW5008381
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 22, 2008
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PLASTIC GUARD MELTED DURING USE AND DRILL BIT BENT DURING USE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: INTRAOPERATIVE DENTAL PROCEDURE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENT CORE IMPACTION DRILL DZA STRYKER INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1