BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 9788595 · Received March 4, 2020

    Report

    Report Number
    3034525-2020-00030
    Event Type
    Injury
    Date Received
    March 4, 2020
    Date of Event
    January 6, 2020
    Report Date
    February 24, 2020
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    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 EXPLANT WAS PAIN. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. A SECOND SURGERY WAS PERFORMED TO REMOVE THE NAIL. REMOVAL DOES NOT INDICATE A DEFECT IN THE PRODUCT OR A FAILURE OF THE IMPLANT. A MINIMAL RISK IS ASSOCIATED WITH THIS FAILURE. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET 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 EXPLANT WAS PAIN. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. A SECOND SURGERY WAS PERFORMED TO REMOVE THE NAIL. REMOVAL DOES NOT INDICATE A DEFECT IN THE PRODUCT OR A FAILURE OF THE IMPLANT. A MINIMAL RISK IS ASSOCIATED WITH THIS FAILURE. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249507 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R