BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-FIX

    MDR report key: 1578057 · Received January 13, 2010

    Report

    Report Number
    1020279-2010-00007
    Event Type
    Injury
    Date Received
    January 13, 2010
    Date of Event
    December 7, 2009
    Report Date
    January 13, 2010
    Manufacturer
    SMITH NEPHEW INC.
    Product Code
    LYT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO A BROKEN RANCHO CUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-FIX RANCHO CUBE / LYT LYT SMITH NEPHEW INC. 08MM09712

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R