BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R-HEAD RECON HEAD

    MDR report key: 2428566 · Received January 20, 2012

    Report

    Report Number
    3003640913-2012-00006
    Event Type
    Injury
    Date Received
    January 20, 2012
    Date of Event
    December 23, 2011
    Report Date
    January 20, 2012
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    KWI
    PMA / PMN Number
    K023604
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF SURGERY REPORT STATES THAT HEAD HAD BEEN WORN FOR 4 YEARS AND THAT THE HEAD DISPLACES THEN THE PT FELL. EVALUATION OF EXPLANTED HEAD SHOWED WEAR AND MARKS FROM BEING DISASSOCIATED FROM STEM. ALSO SHOWED MARKS OF IMPACTION POSSIBLY FROM FALL.

    Description of Event or Problem · 1

    R-HEAD RECON HEAD WAS REVISED IN A PT AFTER A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R-HEAD RECON HEAD RADIAL HEAD PROSTHESIS KWI SMALL BONE INNOVATIONS, INC. RCN-H3

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other