BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRG-0

    MDR report key: 1003938 · Received February 1, 2008

    Report

    Report Number
    1003938
    Event Type
    Malfunction
    Date Received
    February 1, 2008
    Date of Event
    December 19, 2007
    Report Date
    January 31, 2008
    Manufacturer
    ACRA-CUT, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE DRILL THE PERFORATOR DID NOT STOP TURNING WHEN IT GOT PAST BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRG-0 CRANIAL PERFORATOR HBF ACRA-CUT, INC. DGR-0 6280

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR