BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAX DYNAMIC ASSEMBLY RED

    MDR report key: 486796 · Received October 1, 2003

    Report

    Report Number
    8030968-2003-00003
    Event Type
    Injury
    Date Received
    October 1, 2003
    Date of Event
    June 8, 2003
    Report Date
    September 26, 2003
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON GETTING OUT OF BED THE TRIAX WAS FRACTURED AND REQUIRED REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAX DYNAMIC ASSEMBLY RED INSTRUMENT LXH STRYKER TRAUMA SA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention