BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA BLOCKER

    MDR report key: 653181 · Received December 13, 2005

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    Report

    Report Number
    9617544-2005-00089
    Event Type
    Injury
    Date Received
    December 13, 2005
    Date of Event
    November 10, 2005
    Report Date
    November 16, 2005
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2005 THE PT WHO HAS DIABETES MELLITUS HAD PLF AND REDUCTION FROM T8-L2 WITH XIA FOR T11 COLLAPSE. IN NOV. IT WAS FOUND THAT THE WOUND WAS INFECTED FOR THE MRSA. THE SURGEON WILL HAVE ANOTHER SURGERY FOR THE PT TO CLEANSE WITH SALINE CONTAINING ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA BLOCKER IMPLANT KWP STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R