BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL GUIDE, FOR 2.0/2.3MM POSITIONING SCREWS

    MDR report key: 2030676 · Received March 18, 2011

    Report

    Report Number
    8010177-2011-00078
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 25, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR RETURN. INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    A SURGEON WAS USING ONE OF OUR DRILL BITS, DRILL GUIDE AND THE TROCAR. THE PT WAS BURNED IN THE CORNER OF THE MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL GUIDE, FOR 2.0/2.3MM POSITIONING SCREWS INSTRUMENT HWE STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other