BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I.M. NAIL

    MDR report key: 2655802 · Received August 12, 2009

    Report

    Report Number
    3034525-2009-00015
    Event Type
    Injury
    Date Received
    August 12, 2009
    Date of Event
    July 23, 2009
    Report Date
    August 5, 2009
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ST
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE: 07/20/2006 OR 06/13/2007.

    Description of Event or Problem · 1

    PATIENT ELECTED TO HAVE THE NAIL REPLACED AFTER FRACTURE SITE WAS HEALED.

    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 000357-16-1 OR 000606-6-1

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization