BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE CRANIAL PERFORATOR

    MDR report key: 2728907 · Received June 29, 2012

    Report

    Report Number
    2728907
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Date of Event
    June 25, 2012
    Report Date
    June 28, 2012
    Manufacturer
    ACRA-CUT, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CRANIOTOMY FOR CRANIOSYNOSTOSIS A DURAL TEAR OCCURRED. DURING THE SECOND BUR HOLE THE CLUTCH FAILED ON THE DRILL AND THE DURA AND THE UNDERLYING BRAIN WERE TORN. GELFOAM WAS APPLIED OVER THE AREA. A SUBSEQUENT CT SCAN SHOWED A PIECE OF BONE 7MM DOWN IN THE BRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CRANIAL PERFORATOR HUDSON END MINI 11/7 MM HBF ACRA-CUT, INC. 8029

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Other