BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL TIBIAL TRAY IMPACTOR TIP

    MDR report key: 3173214 · Received May 31, 2013

    Report

    Report Number
    3004153240-2013-00087
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 9, 2013
    Manufacturer
    CONFORMIS
    Product Code
    LXH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PERIODIC REVIEW OF ITEMS REMOVED FROM ITOTAL REUSABLE INSTRUMENT TRAYS DURING RE-PROCESSING WAS COMPLETED. THE REVIEW SHOWED THAT FOUR TIBIAL TRAY IMPACTOR TIPS HAD BROKEN. REVIEW OF INSPECTION RECORDS FOR THE AFFECTED LOTS INDICATES THAT THE IMPACTOR TIPS WERE MANUFACTURED 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 FOUR TIBIAL TRAY IMPACTOR TIPS HAD BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241786 ITOTAL TIBIAL TRAY IMPACTOR TIP REUSABLE IMPACTOR COMPONENT LXH CONFORMIS K120801/G1210

    Patients

    Seq Age Sex Outcome Treatment
    1