BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOSOURCE

    MDR report key: 222000 · Received May 7, 1999

    Report

    Report Number
    222000
    Event Type
    Injury
    Date Received
    May 7, 1999
    Date of Event
    April 23, 1999
    Report Date
    May 6, 1999
    Manufacturer
    ALLOSOURCE
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CORTICAL STRUT WAS HANDED ON TO A STERILE FIELD BY THE CIRCULATING NURSE. THE OR TECH OPENED THE INNER PACKAGE AND CULTURED THE CORTICAL STRUT ACCORDING TO THE FACILITY'S "BONE BANK PROTOCOL". THE CORTICAL STRUT WAS IMPLANTED. THE CULTURE WAS FOUND TO GROW OUT ENTEROCOCCUS GALLINARIUM (GRP D) + STAPH EPI FROM THE THIO BROTH. THE SURGEON CONSIDERED RE-OPENING THE WOUND AND REMOVING THE CORTICAL STRUT, BUT WAS ADVISED BY AN INFECTIOUS DISEASE SPECIALIST TO PLACE THE PT ON A REGIMEN OF 3 WEEKS OF ANTIBIOTICS INSTEAD. THE PT DID HAVE SOME SUPERFICIAL CELLULITIS AND BLISTERS POST-OP, BUT THIS WAS BELIEVED TO HAVE BEEN FROM THE TAPE. THE ULTIMATE DAMAGE OR CONSEQUENCES IS NOT YET KNOWN AS THIS IS AN IMPLANTABLE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOSOURCE Implant CORTICAL STRUT LMO ALLOSOURCE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention