BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSTEOFIL ICM MOLDABLE STRIP

    MDR report key: 640225 · Received October 6, 2005

    Report

    Report Number
    3002719998-2005-00011
    Event Type
    Other
    Date Received
    October 6, 2005
    Date of Event
    September 1, 2005
    Report Date
    October 5, 2005
    Manufacturer
    REGENERATION TECHNOLOGIES, INC.
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CERVICAL C6-7 OPEN REDUCTION WITH FUSION INSTRUMENTATION. OSTEOFIL 90 MM STRIP IMPLANTED. INFECTION DIAGNOSED 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOFIL ICM MOLDABLE STRIP ALLOGRAFT BONE PASTE LMO REGENERATION TECHNOLOGIES, INC. 002390 101031946

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other