BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS BLOCKER

    MDR report key: 2831220 · Received November 6, 2012

    Report

    Report Number
    9617544-2012-00482
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNI
    PMA / PMN Number
    K032394
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT ALSO REFERENCED IN THIS COMPLAINT: CAT: 48552320, LOT: 07C259, OASYS 3.5 X 20MM POLYAXIAL SCREW. CAT: 48552324, LOT: 120402, OASYS 3.5 X 24MM POLYAXIAL SCREW. CAT: 48551000, LOT: 6UB, OASYS BLOCKER. CAT: 48552240, LOT: 5DT, OASYS 3.5 X 240MM ROD. CAT: 48552240, LOT: 676, OASYS 3.5 X 240MM ROD. 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

    AFTER TWO MONTHS OF SURGERY, THE BLOCKER AND SCREW ARE SEPARATED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS BLOCKER IMPLANT MNI STRYKER SPINE BORDEAUX NA 6AF

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R