BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II UNIVERSAL TIGHTENER 5MM

    MDR report key: 1203270 · Received October 14, 2008

    Report

    Report Number
    9617544-2008-00123
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 17, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEAD NURSE REPORTED TO OUR SALES REP THAT SHE WAS OBSERVING A SURGERY PROCEDURE AND THE SURGEON SEEMED TO HAVE PROBLEMS WITH THE TIGHTENER. THE SURGEON NOTICED THAT IT WAS NOT POSSIBLE TO FIX THE SCREWS. ANOTHER TIGHTENER WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA II UNIVERSAL TIGHTENER 5MM INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 07F761

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other