BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEAD RECON HEAD AND STEM

    MDR report key: 1739574 · Received June 25, 2010

    Report

    Report Number
    3003640913-2010-00020
    Event Type
    Injury
    Date Received
    June 25, 2010
    Date of Event
    May 1, 2010
    Report Date
    June 25, 2010
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    JDB
    PMA / PMN Number
    K023604
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL ANALYSIS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT HAD A RADIAL HEAD DISASSOCIATE IN VIVO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEAD RECON HEAD AND STEM PROSTHESIS, ELBOW, HEMI, RADIAL, POLYME JDB SMALL BONE INNOVATIONS, INC. RCN-H3/RCN-S3

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention