BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBULA SHAFT

    MDR report key: 694582 · Received February 16, 2006

    Report

    Report Number
    694582
    Event Type
    Injury
    Date Received
    February 16, 2006
    Date of Event
    January 10, 2006
    Report Date
    February 15, 2006
    Manufacturer
    MUSCULOSKELETAL TRANSPLANT FOUNDATION
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED POST-OPEN REDUCTION WITH INTERNAL FIXATION (CLAVICLE) INFECTION, AS WELL AS HARDWARE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBULA SHAFT BONE SHAFT, TISSUE LMO MUSCULOSKELETAL TRANSPLANT FOUNDATION * *
    2 DBX PUTTY , 5CC DEMINERALIZED BONE MQV MUSCULOSKELETAL TRANSPLANT FOUNDATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R