BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1461914 · Received August 20, 2009

    Report

    Report Number
    1461914
    Event Type
    Malfunction
    Date Received
    August 20, 2009
    Date of Event
    August 4, 2009
    Report Date
    August 20, 2009
    Manufacturer
    STRYKER
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    STRYKER SPINE DRILL BECAME HOT TO THE TOUCH. PHYSICIAN REPORTED DURAL TEAR AS A RESULT OF DRILL MALFUNCTION.MANUFACTURER RESPONSE (AS PER REPORTER) FOR DRILL, STRYKER SPINE DRILLSENDING A REP FOR CONSULTATION SINCE THIS IS NOT THE FIRST TIME WITH SIMILAR CIRCUMSTANCES. NO REPLY AS OF YET

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DRILL, ORTHOPEDIC HTW STRYKER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR NO OTHER THERAPIES| NO OTHER THERAPIES