BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCK TIBIAL ONLAY INSERT-SZ 5-8MM

    MDR report key: 4922954 · Received July 17, 2015

    Report

    Report Number
    3005985723-2015-00127
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 22, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGED INSERT DUE TO SEATING ISSUE INVOLVING A MAKO INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION: VISUAL INSPECTION CONFIRMED THE INSERT WAS DAMAGED DUE TO IMPLANTATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN 2 OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSION: THE INVESTIGATION CONFIRMED THAT THE DEVICE WAS DAMAGED DURING ATTEMPT AT IMPLANTATION. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    TIBIAL INSERT WAS DAMAGED WHILE SURGEON WAS TRYING TO SEAT IT. A SECOND INSERT WAS OPENED AND IMPLANTED. CASE WAS SUCCESSFUL AND NO UNUSUAL CIRCUMSTANCES WERE EXPERIENCED.

    Description of Event or Problem · 1

    TIBIAL INSERT WAS DAMAGED WHILE SURGEON WAS TRYING TO SEAT IT. A SECOND INSERT WAS OPENED AND IMPLANTED. CASE WAS SUCCESSFUL AND NO UNUSUAL CIRCUMSTANCES WERE EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467258 MCK TIBIAL ONLAY INSERT-SZ 5-8MM IMPLANT NPJ MAKO SURGICAL CORP. 12340215

    Patients

    Seq Age Sex Outcome Treatment
    1 Other