BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL PERFORATORS

    MDR report key: 497551 · Received November 17, 2003

    Report

    Report Number
    MW1030244
    Event Type
    Malfunction
    Date Received
    November 17, 2003
    Date of Event
    October 1, 2003
    Report Date
    November 7, 2003
    Manufacturer
    ACRA-CUT, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HERE FOR DBS MICRO-ELECTRODE TESTING. KIMM PERFORATION BIT FAILED TO STOP WHEN PENETRATED INNER TABLE OF SKULL, RESULTING IN DURAL PENETRATION AND CORTICAL DISRUPTION OF THE BRAIN. NO APPARENT INJURY NEUROLOGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRANIAL PERFORATORS CRANIAL DRILLS HBF ACRA-CUT, INC. 200-271 DGR-O 4655

    Patients

    Seq Age Sex Outcome Treatment
    1 *