BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLIF BONE PUSHER ALLOCRAFT

    MDR report key: 744977 · Received June 21, 2005

    Report

    Report Number
    9617544-2005-00042
    Event Type
    Malfunction
    Date Received
    June 21, 2005
    Date of Event
    May 23, 2005
    Report Date
    May 24, 2005
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HXO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO USE TLIF BONE PUSHER TO STRAIGHTEN THE GRAFT IN THE DISC SPACE. AS HE GENTLY TURNED THE HANDLE TO THE PUSHER, ONE OF THE TIPS OF THE INSTRUMENT BROKE OFF INTO THE DISC SPACE. IT WAS NECESSARY FOR THE SURGEON TO BRING THE MICROSCOPE IN TO REMOVE THE BROKEN METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TLIF BONE PUSHER ALLOCRAFT INSTRUMENT HXO STRYKER SPINE BORDEAUX NA 04C582

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other