BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAGEN PLUS DURAL REGENERATION MATRIX 3X3 5 PAC

    MDR report key: 2170149 · Received June 28, 2011

    Report

    Report Number
    1121308-2011-00025
    Event Type
    Other
    Date Received
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    INTEGRA, PLAINSBORO
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE THIRD OF THREE REPORTS INVOLVING DURAGEN PLUS DURAL REGENERATION MATRIX (DP5033) [SAME PRODUCT LOT NUMBER USED BY THE SAME USER FACILITY, SIMILAR ADVERSE EVENT EXPERIENCED, DIFFERENT PTS]. THE PT HAD L3-S1 SPINAL FUSION ON (B)(6) 2011. DURASEAL WITH THE DURAGEN PLUS WAS USED. IT WAS REPORTED THAT THE PT HAD AN INFECTION. ON (B)(6) 2011, THE RESULT OF THE CULTURE WAS STAPHYLOCOCCUS AUREUS AND KLEBSIELLA PNEUMONIA. THE LOCATION OF WHERE THE CULTURE WAS OBTAINED WAS UNK. ADD'L CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN PLUS DURAL REGENERATION MATRIX 3X3 5 PAC NA GXQ INTEGRA, PLAINSBORO 1105307

    Patients

    Seq Age Sex Outcome Treatment
    1