BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIONIC KNEE

    MDR report key: 6976631 · Received October 25, 2017

    Report

    Report Number
    3003764610-2017-00004
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    August 29, 2017
    Report Date
    October 25, 2017
    Manufacturer
    OSSUR H/F
    Product Code
    ISW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AMPUTEE PATIENT FELL WHILE WEARING A PROSTHETIC KNEE AND INCURRED A BROKEN TOE ON SOUND SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757234 SYMBIONIC KNEE PROSTHETIC KNEE ISW OSSUR H/F SMBE7280

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention