BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL TIBIAL TRAY IMPACTOR TIP

    MDR report key: 3192433 · Received June 19, 2013

    Report

    Report Number
    3004153240-2013-00105
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 11, 2013
    Manufacturer
    CONFORMIS, INC.
    Product Code
    LXH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE INSPECTION RECORDS FOR THE AFFECTED LOT INDICATES THAT THE IMPACTOR TIPS WERE MFG TO SPECIFICATION.

    Description of Event or Problem · 1

    PERIODIC REVIEW OF ITEMS REMOVED FROM ITOTAL REUSABLE INSTRUMENT TRAYS DURING RE-PROCESSING WAS COMPLETED. THE REVIEW SHOWED THAT TWO TIBIAL TRAY IMPACTOR TIPS HAD BROKEN AT THE POINT WHERE THE TIPS CONNECT TO THE REUSABLE IMPACTOR HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278863 ITOTAL TIBIAL TRAY IMPACTOR TIP REUSABLE IMPACTOR COMPONENT LXH CONFORMIS, INC. K120801

    Patients

    Seq Age Sex Outcome Treatment
    1