BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX

    MDR report key: 1636869 · Received March 19, 2010

    Report

    Report Number
    1636869
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    February 6, 2010
    Report Date
    March 19, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING A CRANIOTOMY FOR A SUBDURAL HEMATOMA, AND RESECTION OF A BRAIN TUMOR. DURING THE PROCEDURE, THE DRILL GUARD ON THE MIDAS REX DRILL, BROKE INTO PIECES. ALL THE PIECES WERE RECOVERED BY THE SURGEON. PROCEDURE COMPLETED WITH ANOTHER MIDAS REX DRILL. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDAS REX DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) HBF MEDTRONIC SOFAMOR DANEK USA, INC * 87802-02

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR