BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SBI LATERAL RHEAD IMPLANT, SIZE 3

    MDR report key: 1233926 · Received November 14, 2008

    Report

    Report Number
    3003640913-2008-00003
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 14, 2008
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    KWI
    PMA / PMN Number
    K062898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF PATIENT FOLLOW UP IMAGES CONFIRMED DISASSOCIATION OF RADIAL HEAD FROM STEM. DIMENSIONAL EVALUATION OF EXPLANTED DEVICE SHOWED DEVICE MEASUREMENTS WERE WITHIN SPECIFICATION. DEVICE HISTORY RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    EXPLANT OF LATERAL RHEAD HEAD AND STEM, DUE TO DISASSOCIATION OF HEAD FROM STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SBI LATERAL RHEAD IMPLANT, SIZE 3 REDIAL HEAD PROSTHESIS KWI SMALL BONE INNOVATIONS, INC. 310-0009 38554002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STEM: LOT# 385450002