BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS

    MDR report key: 3983880 · Received June 23, 2014

    Report

    Report Number
    3005985723-2014-00081
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN RESULTS ARE OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANT SYS. DURING BONE REGISTRATION, THE SURGEON COULD NOT CAPTURE AN ACCEPTABLE TIBIAL CHECKPOINT VALUE, AND HAD TO REPEAT BONE REGISTRATION SEVERAL TIMES. THE SOFTWARE REPORTEDLY APPEARED TO BE LAGGING AS COMPARED TO AN AVERAGE CASE. THE SURGEON COMPLETED THE CASE MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366685 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 20100

    Patients

    Seq Age Sex Outcome Treatment
    1 RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANT SYS