BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I.M. NAIL

    MDR report key: 1202934 · Received October 17, 2008

    Report

    Report Number
    3034525-2008-00005
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    January 5, 2008
    Report Date
    April 7, 2008
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT OF PT WITH BROKEN SIGN NAIL. I.M. NAIL WAS PLACED IN 2003, AND FOUND TO BE BROKEN ON FOLLOW UP AT THE DISTAL FEMUR, AS A RESULT OF ADDITIONAL TRAUMA (PT FELL). THE BROKEN NAIL WAS REMOVED, AND WAS REPLACED WITH A NEW SIGN NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGN I.M. NAIL STANDARD I.M. NAIL HSB SURGICAL IMPLANT GENERATION NETWORK (SIGN) 100360 INV-046-IMP-061-100360 OR INV-

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R