BEUDAMED
    FDA Adverse Event Other Summary report: N

    EQUINOXE

    MDR report key: 3143227 · Received May 28, 2013

    Report

    Report Number
    1038671-2013-00045
    Event Type
    Other
    Date Received
    May 28, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 28, 2013
    Manufacturer
    EXATECH INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED DEVICES WERE NOT RETURNED TO MANUFACTURER FOR EVALUATION. ADDITIONALLY, THE DEVICE CATALOG/SERIAL NUMBERS WERE NOT REPORTED PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    REVISION OF SHOULDER COMPONENTS DUE TO LOOSENING AND POTENTIAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233529 EQUINOXE SHOULDER COMPONENTS HSD EXATECH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention