BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX HYBRID THREE-LEVEL PLATE, SIZE 51MM

    MDR report key: 1192788 · Received October 8, 2008

    Report

    Report Number
    9617544-2008-00121
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K040261
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED "REVISION CASE, PLATE BROKE UPON REMOVAL. SURGEON IS NOTIFYING PATIENT OF PRODUCT FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX HYBRID THREE-LEVEL PLATE, SIZE 51MM IMPLANT KWQ STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention