BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSENSOR VERASENSE KNEE SYSTEM

    MDR report key: 6092304 · Received November 7, 2016

    Report

    Report Number
    MW5065944
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ORTHOSENSOR 1855 GRIFFIN ROAD
    Product Code
    ONN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS ACTIVATED THEN PROPERLY TRANSFERRED TO STERILE FIELD. DEVICE THEN DISCONNECTED FROM THE RECEIVER, AND NO LONGER TRANSMITTED DATA. THIS WAS DISCOVERED WHILE ATTEMPTING TO ZERO THE DEVICE. ALTHOUGH TROUBLESHOOTING ATTEMPTS WERE MADE, THE DEVICE WAS NEVER AGAIN ABLE TO TRANSMIT DATA, AND SO WAS NOT INSERTED IN THE PATIENT. THE DEVICE WAS RETURNED TO SPONSOR FOR REIMBURSEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735982 ORTHOSENSOR VERASENSE KNEE SYSTEM VERASENSE KNEE SYSTEM FOR JOURNEY II BCS ONN ORTHOSENSOR 1855 GRIFFIN ROAD 051315V12704

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR