BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

    MDR report key: 3749427 · Received April 14, 2014

    Report

    Report Number
    2520274-2014-10779
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Report Date
    March 25, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PARK SS., NOH H., KAM M., (2013), RISK FACTORS FOR OVERGROWTH AFTER FLEXIBLE INTRAMEDULLARY NAILING FOR FRACTURES OF THE FEMORAL SHAFT IN CHILDREN, THE BONE AND JOINT JOURNAL, 95; 254-258. THIS REPORT IS FOR AN UNKNOWN TITANIUM ELASTIC NAIL. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: PARK SS., NOH H., KAM M., RISK FACTORS FOR OVERGROWTH AFTER FLEXIBLE INTRAMEDULLARY NAILING FOR FRACTURES OF THE FEMORAL SHAFT IN CHILDREN, THE BONE AND JOINT JOURNAL, 95; 254-258. THE REPORTS OF GOOD RESPONSES USING A FLEXIBLE INTRAMEDULLARY NAIL FOR THE TREATMENT OF FEMORAL FRACTURE HAVE BECOME THE PREFERRED TREATMENT CHILDREN AT LEAST THAN THREE YEARS OLD. IN THIS ARTICLE, HOSPITAL SURGICAL RECORDS WERE REVIEWED FROM MAY 2001 AND OCTOBER 2009. A TOTAL OF 43 CHILDREN BETWEEN THE AGES OF THREE AND (B)(6) WHO HAVE BEEN TREATED WITH OUR PRODUCT, TWO TITANIUM ELASTIC NAILS. THE RESULTS OF THIS ARTICLE FOCUSED ON SHORTENING OR OVERGROWTH OF THE LEG-LENGTH AFTER FLEXIBLE INTRAMEDULLARY NAILING IN CHILDREN. IT HAS BEEN REPORTED THAT THREE PATIENTS HAD SKIN EROSION WITH PROMINENT, PALPABLE NAILS, AND ONE PATIENT HAD GENU VALGUM. ALTHOUGH MOST COMPLICATIONS FOLLOWING FLEXIBLE INTRAMEDULLARY NAILING ARE MINOR, A (B)(6) RATE OF MAJOR COMPLICATIONS HAS BEEN REPORTED. AMONG THESE, AS MANY AS ONE-THIRD OF PATIENTS HAVE LEG-LENGTH DISCREPANCY, DUE TO EITHER SHORTENING GAT THE FRACTURE SITE OR OVERGROWTH THROUGH STIMULATION OF THE PHYSIS. OVERALL, PATIENTS HAD LESS THAN TWO CENTIMETER OF OVERGROWTH OF THE AFFECTED LEG. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227943 APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1