BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 4974836 · Received August 5, 2015

    Report

    Report Number
    3034525-2015-00126
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 2, 2015
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THERE IS NO WAY TO PREDICT A NON-UNION OR FAILURE TO HEAL. THE FIRST IM NAIL WAS REPLACED WITH A 8MM X 280MM, STANDARD NAIL USING TWO PROXIMAL SCREWS AND ONE DISTAL SCREW. SIGN FRACTURE CARE INTERNATIONAL WILL CONTINUE TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET ACTIVITIES.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THERE IS NO WAY TO PREDICT A NON-UNION OR FAILURE TO HEAL. THE SECOND IM NAIL WAS REPLACED WITH A 10MM X 280MM, STANDARD NAIL USING TWO PROXIMAL SCREWS AND ONE DISTAL SCREW. SIGN FRACTURE CARE INTERNATIONAL WILL CONTINUE TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET ACTIVITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015, THAT A SIGN IM NAIL IMPLANTED TO TREAT A FRACTURE OF THE RIGHT TIBIA; WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015, THAT A SIGN IM NAIL IMPLANTED TO TREAT A FRACTURE OF THE RIGHT TIBIA; WAS REPLACED DUE TO NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514599 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R