BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEAD RECON RADIAL HEAD IMPLANT

    MDR report key: 3874003 · Received June 5, 2014

    Report

    Report Number
    3003640913-2014-00042
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    July 26, 2013
    Report Date
    August 30, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    KWI
    PMA / PMN Number
    K011819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: MODEL#: RHA-S3. SURGERY REPORT WAS REVIEWED AND NO DEFINITIVE CONCLUSIONS COULD BE MADE.

    Description of Event or Problem · 1

    THE RHEAD RADIAL HEAD IMPLANT FROM THE UNI-ELBOW RADIO CAPITELLUM SYSTEM WAS REVISED TO ADDRESS THE RADIAL HEAD LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328451 RHEAD RECON RADIAL HEAD IMPLANT PROSTHESIS,ELBOW,HEMI,RADIAL,POLYMER KWI SMALL BONE INNOVATIONS, INC. 410-0005

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention