BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM

    MDR report key: 4232273 · Received October 21, 2014

    Report

    Report Number
    3005985723-2014-00173
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    OLO
    PMA / PMN Number
    K112507
    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

    FOLLOWING A MAKO PROCEDURE, IT WAS NOTICED THAT THERE WAS A CUT IN THE AC POWER CORD OF THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). THERE WAS NOT A CASE DELAY NOR CANCELLATION OF FUTURE SURGERIES AS A MAKO FIELD SVC ENGINEER WAS ABLE TO SUCCESSFULLY REPLACE THE POWER CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668033 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM STEREOTAXIC DEVICE OLO MAKO SURGICAL 204000

    Patients

    Seq Age Sex Outcome Treatment
    1