BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIGEN

    MDR report key: 1897083 · Received November 11, 2010

    Report

    Report Number
    8010764-2010-00013
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 11, 2010
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW FRACTURED AFTER IMPLANTATION REQUIRING A REVISION SURGERY TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIGEN SCREW HWC SMITH & NEPHEW, INC. 08KT25311

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R 71646132/ 06MT04254| 71642135/ 08LM05320| 71642135/ 08LM06520 (X2)