BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 4730823 · Received April 27, 2015

    Report

    Report Number
    3005985723-2015-00052
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Date of Event
    January 29, 2015
    Report Date
    March 19, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. WHEN THE SURGEON WAS IMPACTING THE TIBIAL INSERT TRIALS, THE TIP OF THE TIBIAL IMPACTOR BROKE. THE BREAKAGE DID NOT DELAY OR AFFECT THE OUTCOME OF THE CASE, WHICH WAS SUCCESSFUL.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. WHEN THE SURGEON WAS IMPACTING THE TIBIAL INSERT TRIALS, THE TIP OF THE TIBIAL IMPACTOR BROKE. THE BREAKAGE DID NOT DELAY OR AFFECT THE OUTCOME OF THE CASE, WHICH WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275450 TIBIAL INLAY IMPACTOR HEAD STEROTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other