BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS BLOCKER

    MDR report key: 1192423 · Received October 7, 2008

    Report

    Report Number
    9617544-2008-00116
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    August 8, 2008
    Report Date
    September 10, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    K032394
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. IF MADE AVAILABLE, THE INFO WILL BE PROVIDED IN A SUPPLEMENTAL WITH THE METHOD AND RESULT CODES FOLLOWING AN ENGINEERING EVAL.

    Description of Event or Problem · 1

    THE NUT AND THE INTERNAL FIXATION ROD LOOSED AND SLIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS BLOCKER IMPLANT KWP STRYKER SPINE BORDEAUX NA MKA, MYS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R