BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIONIC LEG 3

    MDR report key: 7820748 · Received August 27, 2018

    Report

    Report Number
    3003764610-2018-00002
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    July 19, 2018
    Report Date
    August 27, 2018
    Manufacturer
    ÖSSUR HF
    Product Code
    ISW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REPORTED TO HAVE FALLEN WHILE WALKING THE STAIRS DUE TO THE KNEE, AND INDICATED THE ELECTRONICS SOMETIMES STOP WORKING WITHOUT ANY REASON. HE IS NOT INJURED. THE PRODUCT IS CURRENTLY AT OSSUR QUALITY CENTER PENDING INVESTIGATION. DURING THE GENERAL QUALITY CHECK THE LEG DID PASS ALL THE TESTS IMPLYING GOOD FUNCTIONALITY OF THE PRODUCT. HOWEVER, THE ERROR LOG SHOWED THAT THE ELECTRONIC ERRORS THE USER EXPERIENCED DURING USE INDEED APPEARED, INDICATING MALFUNCTIONING OF THE LEG MIGHT HAVE CONTRIBUTED TO THE EVENT. ISSUE AT THIS MOMENT SEEMS TO BE A UNIQUE CASE. ISSUE WILL BE FURTHER INVESTIGATED TO DETERMINE ROOT CAUSE AND NECESSARY ACTIONS. NO INITIAL CORRECTIVE/PREVENTIVE ACTIONS ARE CONSIDERED WARRANTED BASED ON INFORMATION CURRENTLY AVAILABLE. THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED TO HAVE FALLEN WHILE WALKING THE STAIRS DUE TO THE KNEE, AND INDICATED THE ELECTRONICS SOMETIMES STOP WORKING WITHOUT ANY REASON. HE IS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662184 SYMBIONIC LEG 3 SYMBIONIC LEG 3 ISW ÖSSUR HF SMBE5260

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR