BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER TORQUE DEFINING SCREW

    MDR report key: 1031155 · Received April 16, 2008

    Report

    Report Number
    1038671-2008-00016
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE HISTORY RECORD PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO PRODUCT REQUIREMENTS. EVALUATION OF IMMEDIATE POST OPERATIVE X-RAYS FROM PRIMARY SURGERY AND X-RAYS AFTER HUMERAL DISASSOCIATION REVEALED THE GLENOSPHERE WAS NOT FULLY SEATED AFTER THE PRIMARY SURGERY, BUT AT SOME POINT (PRESUMABLY DURING THE NORMAL PHYSIOLOGICAL LOADING) THE GLENOSPHERE SEATED ITSELF. THE SEATING OF THE GLENOSPHERE RESULTED IN THE GLENOSPHERE LOCKING SCREW SITTING PROUD OF THE GLENOSPHERE APICAL HOLE RESULTING IN THE GLENOSPHERE LOCKING SCREW DIGGING INTO THE HUMERAL LINER.

    Description of Event or Problem · 1

    DISASSOCIATION OF HUMERAL COMPONENT FROM HUMERAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUINOXE REVERSE SHOULDER TORQUE DEFINING SCREW TORQUE DEFINING SCREW KWS EXACTECH, INC. 22436002

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R