BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCK TIBIAL ONLAY INSERT-SZ 5-8MM

    MDR report key: 4924890 · Received July 20, 2015

    Report

    Report Number
    3005985723-2015-00128
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 25, 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

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLEGED DAMAGED INSERT DURING A PROCEDURE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE REVIEW OF THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED ON 31-MAR-2015. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE DEVICE IS DAMAGED ON THE INFERIOR AND SUPERIOR SIDE DUE TO ATTEMPT AT IMPLANTATION. MACHINE MARKINGS ARE STILL PRESENT. THERE ARE NO SIGNS OF DELAMINATION OR DISCOLORATION. 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.

    Description of Event or Problem · 1

    MAKO 5X8MM INSERT WAS DAMAGED WHILE SURGEON WAS TRYING TO SEAT IT ON MAKO BASEPLATE. COMPONENT WAS KEPT BY REP, AND CASE WAS UNAFFECTED AND SUCCESSFUL. ANOTHER 5X8MM TIBIAL INSERT WAS USED. NO UNUSUAL CIRCUMSTANCES EXPERIENCED.

    Description of Event or Problem · 1

    MAKO 5X8MM INSERT WAS DAMAGED WHILE SURGEON WAS TRYING TO SEAT IT ON MAKO BASEPLATE. COMPONENT WAS KEPT BY REP, AND CASE WAS UNAFFECTED AND SUCCESSFUL. ANOTHER 5X8MM TIBIAL INSERT WAS USED. NO UNUSUAL CIRCUMSTANCES EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470182 MCK TIBIAL ONLAY INSERT-SZ 5-8MM IMPLANT NPJ MAKO SURGICAL CORP. 12340215

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other