BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIGEN

    MDR report key: 2831826 · Received November 14, 2012

    Report

    Report Number
    1020279-2012-00621
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIGEN META-NAIL TIBIAL 8.5MM X 28CM JDS SMITH & NEPHEW, INC. 10GT44804

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R (B)(4) INT HEX CAP SCREW 4.5MM X 40MM| (B)(4) INT HEX CAP SCREW 4.5MM X 30MM| (B)(4) INT HEX CAP SCREW 4.5MM X 35MM| (B)(4) INT HEX CAP SCREW 4.5MM X 25MM