BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA ROD DIA. 6 X 400

    MDR report key: 1991023 · Received February 11, 2011

    Report

    Report Number
    9617544-2011-00050
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 18, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE EVENT DESCRIPTION, IT APPEARS THAT AN INFECTION RESULTED AFTER THE PRIMARY SURGERY AND A REVISION PROCEDURE WAS PERFORMED TO REMOVE THE IMPLANTS. NO PRODUCT WAS RECEIVED TO DATE FOR EVALUATION. HOWEVER ONCE WASHED, CLEANED AND STERILIZED IT IS UNLIKELY THAT PRODUCT WOULD PRESENT OTHER SIGNS BUT SIGNS OF USE AS THE DEVICE WAS PUT IN PLACE AND REMOVED. REPORTED BATCH NUMBER IS (B)(4) MANUFACTURED IN NOVEMBER 24, 2008. ADDITIONAL INFO WAS REQUESTED BUT NO PRODUCT OR ADDITIONAL INFO RECEIVED AT THIS TIME.

    Description of Event or Problem · 1

    IN THE SURGERY, WHEN THE DOCTOR TOOK THE SCREW OUT, HE FOUND NEARLY PARENCHYMA BECAME BLACK AND SMELL METAL AND ODOROUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA ROD DIA. 6 X 400 IMPLANT NKB STRYKER SPINE BORDEAUX NA XG4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other