BEUDAMED
    FDA Adverse Event Other Summary report: N

    RHEAD RECON HEAD

    MDR report key: 1694435 · Received May 6, 2010

    Report

    Report Number
    3003640913-2010-00012
    Event Type
    Other
    Date Received
    May 6, 2010
    Date of Event
    April 9, 2010
    Report Date
    May 6, 2010
    Manufacturer
    SMALL BONE INNOVATIONS
    Product Code
    KWI
    PMA / PMN Number
    K023604
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT WAS NOT REMOVED. DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED NO ANOMALIES. SURGEON MONITORED PT POST-OP AND AT 28 DAYS THE PT HAD NO INFECTION.

    Description of Event or Problem · 1

    EXPIRED RADIAL HEAD COMPONENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEAD RECON HEAD RADIAL HEAD KWI SMALL BONE INNOVATIONS RCN-H3 46138003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other