BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS

    MDR report key: 4231941 · Received October 17, 2014

    Report

    Report Number
    3005985723-2014-00171
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 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 FOLLOW-UP, AN EVALUATION OF THE EVENT IS BEING CONDUCTED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL RESULTS ARE OBTAINED.

    Description of Event or Problem · 1

    DURING THE CASE FOR A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS (RIO), THE VARIABLE ANGLE END EFFECTOR BROKE (THE SPRING LOAD). THERE WAS NO KNOWN HARM TO THE PT NOR CASE DELAY. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662169 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS STEREOTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL 206967

    Patients

    Seq Age Sex Outcome Treatment
    1