BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXION INTRAMEDULLARY NAIL

    MDR report key: 350882 · Received September 3, 2001

    Report

    Report Number
    9615128-2001-00002
    Event Type
    Malfunction
    Date Received
    September 3, 2001
    Date of Event
    May 29, 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. 5-WEEKS POST-OPERATION IN A ROUTINE VISIT, A BROKEN DISTAL TIP OF THE NAIL WAS OBSERVED. SEVEN WEEKS LATER, IT WAS DECIDED TO REMOVE THE NAIL. NAIL WAS REMOVED AND REPLACED WITH ANOTHER NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39888 FIXION INTRAMEDULLARY NAIL INTRAMEDULLARY NAIL HSB DISC-O-TECH MEDICAL TECHNOLOGIES LTD. NA F-772

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention