BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 743351 · Received June 8, 2005

    Report

    Report Number
    MW1035700
    Event Type
    Malfunction
    Date Received
    June 8, 2005
    Date of Event
    May 24, 2005
    Report Date
    May 24, 2005
    Manufacturer
    REP. SUPPLIED INSTRUMENTATION
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USED AS A SPACER IN DISC SPACE FOR PLACEMENT OF CAGE. CRNA NOTICED THAT TIP OF INSTRUMENT WAS MISSING WHEN SHE COMPARED IT WITH ANOTHER INTACT INTERBODY SPACER INSTRUMENT ON FIELD. C-ARM WAS USED TO LOCATE THE PIECE MISSING FROM THE SPACER, GRASPING INSTRUMENTS WERE USED TO RETRIEVE THE PIECE. MISSING PIECE WAS SUCCESSFULLY REMOVED FROM THE PT AND C-ARM WAS USED TO MAKE SURE ALL THE MISSING PIECES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INTERBODY SPACER / SPREADER MQP REP. SUPPLIED INSTRUMENTATION EIB *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR