BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I. M. NAIL

    MDR report key: 2004037 · Received February 23, 2011

    Report

    Report Number
    3034525-2011-00012
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 21, 2011
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTS NEED TO DO EXCHANGE NAIL TO RE-SET THE NONUNION. NO INDICATION OF BROKEN NAIL. NO INDICATION OF PRODUCT DEFECT.

    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) 80380 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization