BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMMETRY SYSTEM

    MDR report key: 6092998 · Received November 10, 2016

    Report

    Report Number
    3008875054-2016-00022
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 19, 2016
    Report Date
    November 10, 2016
    Manufacturer
    ZYGA TECHNOLOGY, INC.
    Product Code
    LXH
    PMA / PMN Number
    K151818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SIJ FUSION SURGERY A HARDENED AREA WITHIN THE JOINT WAS NOTED DURING THE SECOND DECORTICATION. THEY FORCED THE DECORTICATOR CUTTING ELEMENT THROUGH THE HARDENED AREA CAUSING THE TIP OF THE ELEMENT TO BREAK OFF WITHIN THE JOINT. THE SURGEON DID NOT ATTEMPT TO RETRIEVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744465 SIMMETRY SYSTEM SIMMETRY LXH ZYGA TECHNOLOGY, INC. 40144 161174

    Patients

    Seq Age Sex Outcome Treatment
    1