BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX III

    MDR report key: 369903 · Received January 3, 2002

    Report

    Report Number
    369903
    Event Type
    Malfunction
    Date Received
    January 3, 2002
    Date of Event
    December 20, 2001
    Report Date
    December 28, 2001
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY FOR REMOVAL OF HARRINGTON RODS AND 1-LEVEL POSTERIOR LUMBAR INTERBODY FUSION WITH MIDAS REX, THE SURGICAL TECHNICIAN NOTICED AN EXCESS AMOUNT OF LUBRICATING OIL ON THE OUTSIDE OF THE MIDAS REX HAND PIECE. THERE WAS NO OIL NOTED AT THE SURGICAL SITE. THE HANDPIECE WAS TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDAS REX III PNEUMATIC SURGICAL DRILL HBB MEDTRONIC MIDAS REX CE0086 16874H00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other