BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 6146169 · Received December 5, 2016

    Report

    Report Number
    3034525-2016-00311
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 29, 2016
    Report Date
    December 1, 2016
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    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 INFECTION IS UNDETERMINED. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. A SECOND SURGERY WAS PERFORMED TO REPLACE THE IMPLANT. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET ACTIVITIES. THE SURGOEN STATED THAT NO FURTHER TREATMENT IS SCHEDULED AS THE PATIENT HAS BEEN TRANSFERRED TO A DIFFERENT HOSPITAL.

    Description of Event or Problem · 1

    WE BECAME AWARE ON (B)(6) 2016 THAT A SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURE WAS EXCHANGED DUE TO INFECTION. THE IM NAIL WAS REPLACED WITH A 10MM X 280MM, STANDARD NAIL PER THE SIGN TECHNIQUE MANUAL. SURGEON COMMENT: "THERE WAS PRULENT DISCHARGE THROUGH THE SCREW HOLE DISTALLY AND TROCHANTERIC ENTRY. SEEMS TO BE CHEMICA REACTION!! WE DEBRIDED THOROUGHLY AND TOILETED WITH POVIDON IODINE, H2O2 AND NORMAL SALINE. ADDED GENTAMYCIN AFTERWARDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796295 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R