BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXION INTRAMEDULLARY NAIL

    MDR report key: 350943 · Received September 3, 2001

    Report

    Report Number
    9615128-2001-00001
    Event Type
    Malfunction
    Date Received
    September 3, 2001
    Date of Event
    January 10, 2001
    Report Date
    September 3, 2001
    Manufacturer
    DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
    Product Code
    HSB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    APP. 2-MONTH AFTER NAIL REPLACEMENT (POST-TRAUMA), THE NAIL WAS BENT WHEN THE PATIENT WAS PARTIALLY WEIGHT BEARING, WITH A LACK OF TRAUMA REPORTED. THE CALLUS CONDITION AT THAT TIME WAS NOT KNOWN. NAIL WAS REMOVED AND REPLACED WITH ANOTHER NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39830 FIXION INTRAMEDULLARY NAIL INTRAMEDULLARY NAIL HSB DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. NA F-417

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention