BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I. M NAIL

    MDR report key: 2202346 · Received August 5, 2011

    Report

    Report Number
    3034525-2011-00031
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 28, 2011
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DATABASE REPORT OF BROKEN NAIL AT FOLLOW UP. CAUSE OF BREAKAGE WAS FULL WEIGHTBEARING ON A NONUNION. SURGERY REQUIRED TO REPLACE THE I. M 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) UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization