BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 8212962 · Received January 3, 2019

    Report

    Report Number
    3005985723-2019-00021
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 5, 2018
    Report Date
    January 3, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    MAKO PRODUCT SPECIALIST REPORTED THE FOLLOWING EVENT: "THE TIP BROKE WHEN THE SURGEON IMPACTED THE TIBIAL INSERT WITH THE HAMMER. WHAT ACTIONS HAVE BEEN TAKEN TO COMPLETE THE INTERVENTION? NOT USING THE IMPACTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5598 TIBIAL INLAY IMPACTOR HEAD PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other