BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE CAGE SCREW M, 35MM

    MDR report key: 9810634 · Received March 10, 2020

    Report

    Report Number
    1220246-2020-01758
    Event Type
    Injury
    Date Received
    March 10, 2020
    Date of Event
    February 19, 2020
    Report Date
    March 10, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    PMA / PMN Number
    K183914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ECLIPSE TOTAL SHOULDER PROCEDURE, THE SURGEON SAWED THE HUMERAL HEAD OFF, PUT CAP ON THE HUMERUS AND COMPLETED THE GLENOID WITHOUT ISSUE. WHEN THE SURGEON CAME BACK TO COMPLETE THE HUMERUS, THE BONE QUALITY WAS VERY POOR AND THE AR-9301-01 (LOT: 18.01100) CAGE SCREW WOULD NOT HOLD. UPON PULLING OUT THE CAGE SCREW IT WAS NOTED THAT THE SCREW WAS FULL OF BONE. THE SURGEON THEN SWITCHED TO A LONGER CAGE SCREW (AR-9301-02 / LOT: 18.01106) TO GET A DEEPER BITE, BUT IT PULLED OUT AS WELL. THE REP STATED AT THIS POINT THE SURGEON WAS VERY UPSET, AND DECIDED TO REMOVE ALL IMPLANTED PRODUCT AND SWITCH TO AN MGS REVERSE TOTAL SHOULDER. THE REP REPORTED NO ADDITIONAL INCISIONS WERE NEEDED, JUST A DIFFERENT IMPLANT SYSTEM WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THE FOLLOWING PRODUCTS WERE FIRST IMPLANTED, AND THEN IMMEDIATELY EXPLANTED; AR-9301-01 / LOT: 18.01100 - ECLIPSE SMALL CAGE SCREW, AR-9301-02 / LOT: 18.01106 - ECLIPSE MEDIUM CAGE SCREW, AR-9301-41CPC / LOT: 18.01145 - ECLIPSE TRUNNION SIZE 41, AR-9121-01 / LOT: 170139713 - GLENOID INLAY SMALL, AR-9165-25NL / LOT: 10221985 - CENTRAL NON-LOCKING SCREW, AR-9145-36 / LOT: 18.00586 - PERIPHERAL LOCKING SCREW, AR-9145-24 / LOT: 18.00585 - PERIPHERAL LOCKING SCREW, AR-9165-25NL / LOT: 10204555 - CENTRAL NON-LOCKING SCREW (THE REP STATED SCREW WAS DROPPED ON THE FLOOR AND HAD TO BE WASTED), AR-9120-01PC / LOT: 17.01676 - REVERS GLENOID. ALL REMOVED PRODUCTS WERE DISCARDED AND WILL NOT BE RETURNING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277354 ECLIPSE CAGE SCREW M, 35MM TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM 18.01106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other