BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 380844 · Received March 7, 2002

    Report

    Report Number
    2242816-2002-00004
    Event Type
    Injury
    Date Received
    March 7, 2002
    Date of Event
    January 28, 2002
    Report Date
    March 7, 2002
    Manufacturer
    EBI, L.P.
    Product Code
    JEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MD APPLIED FIXATOR FOR A MID-TIBIA FRACTURE. APPROXIMATELY THREE WEEKS LATER, THE LEFT CLAMP REPORTEDLY "FAILED". THE PATIENT SUSTAINED A LOSS OF REDUCTION. A SECOND REDUCTION WAS DONE AND THE FIXATOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX EXTERNAL FIXATION JEC EBI, L.P. 01001 039251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention