BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN ANSPACH

    MDR report key: 2439964 · Received February 2, 2012

    Report

    Report Number
    2439964
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    January 17, 2017
    Report Date
    February 2, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PERFORATOR FAILED TO STOP AFTER IT HAD GONE THROUGH THE CRANIUM AND COULD HAVE HIT THE BRAIN IF IT HAD NOT DEFLECTED FROM THE BONE.THE PERFORATOR APPEARED TO HAVE BEEN LOADED INCORRECTLY AND YET THE DRILL CONTINUED TO SPIN. ABLE TO RECREATE THE PROBLEM WHEN RESEATED INCORRECTLY. THE C-CLAMP FRAME WAS NOT NOTICED TO HAVE ANY FRACTURES BEFORE PROCEDURE.THE MANUFACTURER WILL INTERROGATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN ANSPACH DRILL, CRANIAL PERFORATOR HBF THE ANSPACH EFFORT, INC. 26-1221 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NO OTHER THERAPIES