BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INSERT IMPACTOR TIP

    MDR report key: 5996028 · Received October 4, 2016

    Report

    Report Number
    3004153240-2016-00195
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 4, 2016
    Manufacturer
    CONFORMIS, INC.
    Product Code
    LXH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PERIODIC REVIEW OF ITEMS REMOVED FROM REUSABLE INSTRUMENT TRAYS DURING REPROCESSING WAS COMPLETED. REVIEW SHOWED THAT TWO TIBIAL INSERT IMPACTOR TIPS WERE BROKEN. A REVIEW OF THE LOT HISTORY RECORDS FOR THE AFFECTED COMPONENTS INDICATES THE DEVICES WERE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    PERIODIC REVIEW OF ITEMS REMOVED FROM REUSABLE INSTRUMENT TRAYS DURING REPROCESSING WAS COMPLETED. REVIEW SHOWED THAT TWO TIBIAL INSERT IMPACTOR TIPS WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648642 TIBIAL INSERT IMPACTOR TIP REUSABLE IMPACTOR COMPONENT LXH CONFORMIS, INC. G131601, E140501

    Patients

    Seq Age Sex Outcome Treatment
    1