BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 8375242 · Received February 27, 2019

    Report

    Report Number
    3034525-2019-00028
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    January 23, 2019
    Report Date
    February 14, 2019
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 ROOT CAUSE OF THE NON-UNION IS UNDETERMINED. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THIS FAILURE DOES NOT INDICATE A DEFECT IN THE PRODUCT. A MINIMAL RISK IS ASSOCIATED WITH THIS FAILURE. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 1

    A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ROOT CAUSE OF THE NON-UNION IS UNDETERMINED. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THIS FAILURE DOES NOT INDICATE A DEFECT IN THE PRODUCT. A MINIMAL RISK IS ASSOCIATED WITH THIS FAILURE. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET SURVEILLANCE ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169250 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R