BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I.M. NAIL

    MDR report key: 1212657 · Received October 24, 2008

    Report

    Report Number
    3034525-2008-00021
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    November 28, 2006
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I.M. NAIL BROKE A SHORT TIME POST SURGERY UNDER UNK CONDITIONS. WE REQUESTED ADDITIONAL INFO, HOWEVER NONE HAS BEEN RECEIVED. SURGERY WAS REQUIRED TO REPLACE THE 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) 90340 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R