BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I. M NAIL

    MDR report key: 2202349 · Received August 5, 2011

    Report

    Report Number
    3034525-2011-00033
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 1, 2011
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DATABASE REPORT OF SURGERY TO REMOVE AND REPLACE BENT SCREWS AND I. M NAIL. CAUSE: PT FELL AND CAUSED THE IMPLANTS TO BEND. 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) 90400 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization