BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER

    MDR report key: 692087 · Received March 6, 2006

    Report

    Report Number
    MW1038242
    Event Type
    Injury
    Date Received
    March 6, 2006
    Date of Event
    February 28, 2006
    Report Date
    March 6, 2006
    Manufacturer
    STRYKER/LEIBINGER MIRCRO IMPLANTS
    Product Code
    GXN
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CRANIAL IMPLANT WAS ASSUMED TO BE STERILE AND THE MOLD WAS PLACED ON THE OPERATING ROOM STERILE FIELD, RESULTING IN CONTAMINATION OF THE FIELD. THE CRANIAL IMPLANT WAS NOT INSERTED DUE TO BRAIN SWELLING. THIS WAS A CLOSE CALL. THE LABELING ON THE CRANIAL IMPLANT PACKAGING DOES NOT INDICATE THAT THE PRODUCT IS STERILE. HOWEVER, THE PACKAGE INSERT DOES CLEARLY STATE THAT THE "CUSTOM IMPLANT AND THE HOST-BONE MODEL ARE SUPPLIED NON-STERILE." IT IS FELT THAT THE OUTSIDE PACKAGING SHOULD STATE THAT THE PRODUCT IS NOT STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER STRYKER CUSTOM CRANIAL IMPLANT GXN STRYKER/LEIBINGER MIRCRO IMPLANTS * S355051036G

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other