BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INSERT ONLAY TRIAL-SIZE 3-9MM

    MDR report key: 6225638 · Received January 5, 2017

    Report

    Report Number
    0002249697-2017-00086
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Date of Event
    December 6, 2016
    Report Date
    January 5, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    WHILE IMPACTING THE TIBIA BASEPLATE, THE BLUE PLASTIC PIECE ( PN 160177 LOT 12231214 ) BROKE IN 3 PIECES. ALSO, I NEED A NEW 3X9 POLY AS THE POLY BROKE WHILE EXTRACTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10720 TIBIAL INSERT ONLAY TRIAL-SIZE 3-9MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other