BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER IMPACTION BUR GUARD

    MDR report key: 1781749 · Received July 26, 2010

    Report

    Report Number
    MW5016882
    Event Type
    Malfunction
    Date Received
    July 26, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 26, 2010
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GET
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A FULL MOUTH EXTRACTION USING A STRYKER IMPACTION DRILL AND STRYKER IMPACTION BUR GUARD AND THE PT SUSTAINED A BURN TO HER LIP. DATES OF USE: (B) (6)2010 - (B) (6)2010. DIAGNOSIS OR REASON FOR USE: SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER IMPACTION BUR GUARD BUR GUARD GET STRYKER INSTRUMENTS
    2 STRYKER CORE IMPACTION DRILL DZI STRYKER INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other