BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM POYAXIAL SCREW 7X50MM

    MDR report key: 1970482 · Received January 20, 2011

    Report

    Report Number
    1526439-2011-00002
    Event Type
    Injury
    Date Received
    January 20, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MNH
    PMA / PMN Number
    K062174
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS LIMITED AT THIS TIME. THE DEVICE REMAINS IMPLANTED AND X-RAYS WERE NOT PROVIDED FOR REVIEW. NO CONCLUSIONS CAN BE MADE AT THIS TIME. DEVICE IS INTENDED TO BE A TEMPORARY FIXATION DEVICE TO AID IN THE PROCESS OF FUSION, AND BREAKAGE CAN OCCUR DUE TO DELAYED UNION OR NON-UNION, AS WELL AS CYCLICAL LOADING OF THE DEVICE OVER TIME. NOTCHES, SCRATCHES OR BENDING OF THE IMPLANT DURING THE COURSE OF SURGERY MAY ALSO CONTRIBUTE TO EARLY FAILURE. THESE PRECAUTIONS ARE STATED IN THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    ON 15 JULY 2010, PT HAD SPINAL SURGERY, L2-L5 INSTRUMENTATION WAS PERFORMED. ON (B)(6) 2010, IT WAS FOUND THAT THE SCREW USED AT L5 WAS BROKEN. PT HAS A NON UNION AT L4-L5. THERE IS NO PLAN TO PERFORM ANOTHER SURGERY. THE PT IS BEING MONITORED. AS THIS COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION, AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM POYAXIAL SCREW 7X50MM SPINAL FIXATION DEVICE MNH DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention