BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    MDR report key: 2577625 · Received May 7, 2012

    Report

    Report Number
    3005985723-2012-00128
    Event Type
    Other
    Date Received
    May 7, 2012
    Date of Event
    December 20, 2011
    Report Date
    April 11, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K081867
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP AN EVAL WAS PERFORMED BY MAKO SURGICAL WITH REGARDS TO THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC (RIO). THE RESULTS OF THE EVAL REVEALED NO EVIDENCE OF A SYSTEM RELATED ERROR THAT WOULD HAVE PREVENTED THE SYSTEM FROM ENTERING THE STEREOTACTIC BOUNDARY.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) ON (B)(6) 2011. AFTER CUTTING THE TIBIA AND ONE PEG HOLE, THE SURGEON WAS CONSTRAINED BY THE RIO AND WAS UNABLE TO BURR THE SECOND PEG HOLE. THE SURGEON DETERMINED THAT THE PROPER COURSE OF ACTION WAS TO COMPLETE THE PROCEDURE USING THE MANUAL INSTRUMENT SET AND SURGEON WAS SATISFIED WITH THE OUTCOME OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO STEREOTAXIC INSTRUMENT HAW MAKO SURGICAL 201000

    Patients

    Seq Age Sex Outcome Treatment
    1