BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    MDR report key: 4081016 · Received August 22, 2014

    Report

    Report Number
    3005985723-2014-00116
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 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 HAS BEEN INITIATED AT MAKO SURGICAL. THE EVALUATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN RESULTS ARE OBTAINED.

    Description of Event or Problem · 1

    AN OFFSET REAMER HANDLE USED IN MAKOPLASTY TOTAL HIP ARTHROPLASTY PROCEDURES WITH THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WAS RETURNED TO MAKO SURGICAL WITH A REPORT OF METAL SHAVING DEBRIS COMING FROM THE HANDLE. NO METAL WAS OBSERVED TO HAVE COME IN CONTACT WITH THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508421 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO STEREOTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL 207080 32070412

    Patients

    Seq Age Sex Outcome Treatment
    1 RESTORIS PST/TFS TOTAL HIP IMPLANT SYSTEM