BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA LP POLYAXIAL SCREW 6.5 X 45MM

    MDR report key: 1760630 · Received July 9, 2010

    Report

    Report Number
    9617544-2010-00268
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 8, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    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 WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PRIMARY SURGERY (POSTERIOR FIXATION FOR TH12 FRACTURE) WAS PERFORMED. ON (B)(6) 2010, IT WAS FOUND BY THE X-RAY THAT THE TWO SCREWS AT BOTTOM WERE BACKED OUT. ALSO, THE SURGEON FOUND THAT THE PATIENT FELL TO THE GROUND AND HIT HIS BOTTOM AT SOME POINT ON THE DATES BETWEEN (B)(6) AND (B)(6). THE PATIENT HAS NO PAIN OR COMPLICATION DUE TO THE EVENT, THUS HE IS WEARING A CORSET AT THIS MOMENT AND ON MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA LP POLYAXIAL SCREW 6.5 X 45MM IMPLANT NKB STRYKER SPINE BORDEAUX NA B01336

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR