BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 50 MM

    MDR report key: 1841206 · Received September 7, 2010

    Report

    Report Number
    9617544-2010-00355
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K071373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE IMPLANT WAS INSERTED INTO THE SPINE. AT THE END OF THE CASE, THE DR ATTEMPTED TO INSERT THE ROD AND THE ROD DID NOT FIT. WE REMOVED THE SCREW AND REPLACED IT WITH ANOTHER ONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 50 MM IMPLANT NKB STRYKER SPINE BORDEAUX NA B02853

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK