BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM

    MDR report key: 4092961 · Received September 4, 2014

    Report

    Report Number
    3005985723-2014-00125
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    OLO
    PMA / PMN Number
    K081867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW UP, AN EVAL OF THE EVENT HAS BEEN CONDUCTED AT MAKO SURGICAL. EVAL OF THE RETURNED MOTORS IS ONGOING. A SUPPLEMENTAL REPORT WILL BE FILED IF ADD'L RESULTS ARE OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A BILATERAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. DURING THE CASE, THE BURR MOTOR BEGAN SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541559 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM STEREOTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL 110940

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR