BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM

    MDR report key: 4231796 · Received October 15, 2014

    Report

    Report Number
    3005985723-2014-00167
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    OLO
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT F/U, AN EVAL OF THE EVENT IS BEING CONDUCTED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED IF ADD'L RESULTS ARE OBTAINED.

    Description of Event or Problem · 1

    DURING SET-UP (PRE-SURGERY CHECKS) FOR A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO), THE MAKOPLASTY SPECIALIST WAS UNABLE TO RELEASE THE EMERGENCY STOP AND THUS COULD NOT RELEASE THE ROBOTIC ARM. FURTHER TROUBLESHOOTING ATTEMPTS WERE UNSUCCESSFUL AND THE SURGEON OPTED TO USE A DIFFERENT MFR'S EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652671 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM STEREOTAXIC DEVICE OLO MAKO SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1