BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI CLICK'X LOCKING CAP FOR TI 3-D HEAD

    MDR report key: 1002445 · Received February 21, 2008

    Report

    Report Number
    1719045-2008-00013
    Event Type
    Injury
    Date Received
    February 21, 2008
    Report Date
    January 25, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MNI
    PMA / PMN Number
    K031175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    RECEIVED MAUDE EVENT REPORT SENT TO SYNTHES MONUMENT BY FDA. THE LOCKING CAPS FOR SYNTHES CLICK'X INSTRUMENTATION BECAME LOOSE AND ALLOWED THE RODS AND SCREWS TO BECOME UNSTABLE. THE CAPS WERE REPLACED AND WERE TIGHTENED DOWN AND THE REMAINING INSTRUMENTATION WAS STABILIZED. PT COMPLAINED OF PAIN AND AN X-RAY VERIFIED THE LOCKING CAPS WERE LOOSE. THE INITIAL SURGERY WAS PERFORMED FOR A HERNIATED DISC. THE REVISION SURGERY WAS COMPLETED AND SURGEON KEPT THE SAME RODS AND SCREWS AND ONLY REPLACED THE TWO LOCKING CAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI CLICK'X LOCKING CAP FOR TI 3-D HEAD CLICK'X LOCKING CAPS MNI SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R RODS| SCREWS