BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUINOXE GLENOID, KEELED, SMALL

    MDR report key: 6003930 · Received October 6, 2016

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    Report

    Report Number
    1038671-2016-00651
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    June 18, 2012
    Report Date
    October 6, 2016
    Manufacturer
    EXACTECH, INC
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2011. REVISION OF RIGHT SHOULDER COMPONENTS DUE TO WEAKNESS AND SUBSCAPULARIS TENDON RUPTURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656667 EQUINOXE GLENOID, KEELED, SMALL GLENOID HSD EXACTECH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention