BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM

    MDR report key: 2782055 · Received October 2, 2012

    Report

    Report Number
    3005985723-2012-00210
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 6, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K081867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION WAS CONDUCTED BY MAKO SURGICAL WITH REGARD TO THIS EVENT. PATIENT X-RAYS WERE REVIEWED, AND IT WAS OBSERVED THAT THE SURGEON HAD ATTEMPTED TO INSERT THE BONE PIN ONCE BEFORE REMOVING IT AND INSERTING IT IN A DIFFERENT LOCATION IN THE TIBIA. THE PATIENT HAD AN EXTRA PIN HOLE, WHICH MADE A NOTCH IN THE LATERAL CORTEX OF THE TIBIA, CREATING A STRESS RISER.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A SUCCESSFUL PARTIAL KNEE ARTHROPLASTY CASE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) ON (B)(6) 2012. ABOUT FIVE WEEKS LATER, THE PATIENT SUFFERED A FRACTURE AT THE SITE OF THE TIBIAL BONE PIN HOLE. THE TIBIA WAS PLATED AND NAILED ON THE DATE OF EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RESTORIS MULTICOMPARTMENTAL KNEE PROTHESIS