BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIO SMALL OFFSET CONNECTOR

    MDR report key: 2854614 · Received November 29, 2012

    Report

    Report Number
    9617544-2012-00535
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    K032855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    DURING SURGERY, THE SURGEON USED TRIO SPINE SYSTEM. THE ROD WAS NOT ABLE TO BE INSERTED WHEN THE SURGEON TRIED TO INSERT THE ROD IN THE OFFSET CONNECTOR. THE ROD WAS NOT ABLE TO BE INSERTED ALTHOUGH HE LOOSENED THE SCREW OF THE CONNECTOR. THEREFORE, THE SURGEON CHANGED THE OFFSET CONNECTOR TO ANOTHER OFFSET CONNECTOR AND SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIO SMALL OFFSET CONNECTOR IMPLANT KWP STRYKER SPINE BORDEAUX NA 126357

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK