BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXPOSURE

    MDR report key: 1286766 · Received January 9, 2009

    Report

    Report Number
    2184052-2009-00001
    Event Type
    Other
    Date Received
    January 9, 2009
    Date of Event
    November 23, 2008
    Report Date
    December 9, 2008
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE EXPANDING THE DEVICE IT BROKE AT THE HINGE. A PIECE OF METAL FELL INTO THE WOUND SITE. THE METAL PIECE WAS EASILY REMOVED AND THE CASE COMPLETED WITH ANOTHER INSTRUMENT. THIS ADDED 10-30 MINUTES ADDITIONAL SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXPOSURE FLEXPANDER ASSEMBLY LXH ZIMMER SPINE, INC. EM0060-130

    Patients

    Seq Age Sex Outcome Treatment
    1