BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 3000737 · Received March 12, 2013

    Report

    Report Number
    0001811755-2013-00512
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE PROBABLE CAUSE OF THE DEVICE OVERHEATING WAS ATTRIBUTED TO CORRODED BEARINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MANDIBULAR OSTEOTOMY, THE PATIENT RECEIVED A FIRST DEGREE BURN ON THE LIP. ADDITIONAL ANTIBIOTIC PRESCRIPTION WAS NOT GIVEN BECAUSE THE PATIENT RECEIVED AN ANTIBIOTIC PRIOR TO THE PROCEDURE. THE PATIENT WAS REPORTED AS DOING WELL ON THE FOLLOW UP VISIT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103996 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS-KALAMAZOO 0308402953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other