BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEGEND DRILL

    MDR report key: 2234263 · Received August 30, 2011

    Report

    Report Number
    MW5021957
    Event Type
    Other
    Date Received
    August 30, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 24, 2011
    Manufacturer
    MIDAS REX
    Product Code
    HBB
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, FOOT PEDAL ON THE CRANIOTOME THAT WAS BEING USED BENT AND THE BLADE BROKE. THIS OCCURRED WHILE DRILLING WAS TAKING PLACE. THE DRILL WAS PUT ASIDE AND ANOTHER DRILL WAS ABLE TO BE OBTAINED TO CONTINUE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND DRILL HBB MIDAS REX DRILL 2

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR