BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I. M. NAIL

    MDR report key: 1981046 · Received February 3, 2011

    Report

    Report Number
    3034525-2011-00011
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 1, 2011
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTS THAT PT STARTED FULL WEIGHT BEARING PRIOR TO DOCTOR'S ADVICE. IM NAIL BROKE AT THE FRACTURE SITE. SURGERY DONE TO REPLACE BROKEN NAIL AND RESET NONUNION. 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) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization