BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I.M. NAIL

    MDR report key: 1210731 · Received October 23, 2008

    Report

    Report Number
    3034525-2008-00015
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 2, 2007
    Report Date
    November 6, 2007
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE: UNK

    Description of Event or Problem · 1

    NON-UNION AFTER ONE YR CAUSED THE I.M. NAIL TO BREAK. PT REQUIRED SURGERY TO REPLACE 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) 90320 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R