BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAD CAP RHEAD RADIAL HEAD AND STEM

    MDR report key: 1739577 · Received June 25, 2010

    Report

    Report Number
    3003640913-2010-00021
    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
    K060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION SHOWED DEVICES WITHIN SPECIFICATION. VISUAL EXAMINATION SHOWED DAMAGE TO STEM COMPONENT THAT WOULD PREVENT HEAD FROM FULLY ENGAGING. THIS DAMAGE IS CONSISTENT WITH HEAVY IMPACT ON STEM AS WITH METAL HAMMER.

    Description of Event or Problem · 1

    PATIENT HAD A RADIAL HEAD DISASSOCIATE IN VIVO. NO PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAD CAP RHEAD RADIAL HEAD AND STEM PROSTHESIS, ELBOW, HEMI, RADIAL, POLYME JDB SMALL BONE INNOVATIONS, INC. 410-0006/RHA-S4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention