BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXION INTRAMEDULLARY NAILING SYSTEM

    MDR report key: 380304 · Received February 15, 2002

    Report

    Report Number
    9615128-2002-00001
    Event Type
    Injury
    Date Received
    February 15, 2002
    Date of Event
    January 11, 2002
    Report Date
    February 14, 2002
    Manufacturer
    DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
    Product Code
    HSB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NAIL WAS IMPLANTED IN 2001, DURING A REVISION SURGERY, IN A PATIENT WHO HAD PSEUDOARTHROSIS. A TITANIUM PLATE (OF ANOTHER COMPANY) WAS REMOVED AND REPLACED WITH THE FIXION NAIL. ABOUT 15 WEEKS AFTER IMPLANTATION, THE PATIENT HAD PAINS AND IN AN X-RAYS RADIOGRAPH A SPLIT IN THE NAIL WAS OBSERVED. THE NAIL WAS REMOVED IN ONE PIECE WITH NO FURTHER COMPLICATION IN 2002, AND ANOTHER NAIL WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXION INTRAMEDULLARY NAILING SYSTEM INTRAMEDULLARY FEMORAL NAIL HSB DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. NA F-690C

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention