BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK

    MDR report key: 1791963 · Received August 4, 2010

    Report

    Report Number
    1038671-2010-00116
    Event Type
    Other
    Date Received
    August 4, 2010
    Date of Event
    November 13, 2007
    Report Date
    August 4, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF SHOULDER DEVICES DUE TO POSTOPERATIVE INFECTION. ANTIBIOTIC SPACER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTETRAK PRIMARY HUMERAL STEM KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R