BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA TOTAL FOOT SYSTEM II

    MDR report key: 5789725 · Received July 13, 2016

    Report

    Report Number
    5789725
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    April 28, 2016
    Report Date
    June 21, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON STATES HARDWARE HAS FAILED. INTEGRA LIFE SCIENCES-TOTAL FOOT SYSTEM IIPLATE-2901100 (LOT # 185281), SCREW 2830024, SCREW 2830028, SCREW 2845126, SCREW 440142.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445828 INTEGRA TOTAL FOOT SYSTEM II PLATE, FIXATION, BONE HRS INTEGRA LIFESCIENCES CORPORATION 185281

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR