BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLOGRAFT

    MDR report key: 562055 · Received December 21, 2004

    Report

    Report Number
    562055
    Event Type
    Death
    Date Received
    December 21, 2004
    Date of Event
    May 20, 2004
    Report Date
    December 16, 2004
    Manufacturer
    *
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED AFTER MVA UNDERWENT A POSTEROLATERAL ARTHRODESIS C4 TO T3, SEGMENTAL PEDICLE FIXATION, C4 TO T3, POSTEROLATRAL ALLOGRAFT C4 TO T3 IN 2004. PT SUBSEQUENTLY WAS DIAGNOSED WITH FULMINANT LIVER FAILURE DURING A 9/2004 ADMISSION AND WAS DIAGNOSED AS HEP B POSITIVE. OF THE RISK FOR HEPATITIS, THE PT WAS AN INSULIN DEPENDENT DIABETIC, SURGERY, TRANSFUSION AND ALLOGRAFT. THE PT RECEIVED DEMINERALIZED BONE MATRIX GRAFTS. EXP DATE 2005 AND EXP DATE 2006. INFECTION CONTROL COORDINATOR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOGRAFT ALLOGRAFT LMO * * 005313751132
    2 ALLOGRAFT ALLOGRAFT LMO * * 035343311177

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death