BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN - NAIL

    MDR report key: 3749400 · Received April 14, 2014

    Report

    Report Number
    2520274-2014-10777
    Event Type
    Injury
    Date Received
    April 14, 2014
    Report Date
    March 25, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. DATE OF EVENT: NASCIMENTO, FP., ET. AL., (2013), FLEXIBLE INTRAMEDULLARY NAILS WITH TRACTION VERSUS PLASTER CAST FOR TREATING FEMORAL SHAFT FRACTURES IN CHILDREN: COMPARATIVE RETROSPECTIVE STUDY., SÃO PAULO MEDICAL JOURNAL, 131; 5-12. ADDITIONAL DEVICE INFO: THIS REPORT IS FOR AN UNKNOWN TITANIUM ELASTIC NAIL. IMPLANT/EXPLANT DATE: UNKNOWN. 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: NASCIMENTO, FP., ET. AL., FLEXIBLE INTRAMEDULLARY NAILS WITH TRACTION VERSUS PLASTER CAST FOR TREATING FEMORAL SHAFT FRACTURES IN CHILDREN: COMPARATIVE RETROSPECTIVE STUDY., SÃO PAULO MEDICAL JOURNAL, 131; 5-12. FEMORAL FRACTURES ARE MOST COMMON IN CHILDREN AROUND THE AGES OF TWO THROUGH 12 YEARS OLD. IN THIS STUDY CHILDREN BETWEEN THE AGES OF FIVE THROUGH 14 YEARS OLD WERE RECRUITED TO A STUDY COMPARING A SURGICAL PROCEDURE USING A TITANIUM ELASTIC NAIL (SYNTHES) TO REPAIR A FEMORAL FRACTURE VERSUS TRADITIONAL TRACTION AND CAST. THIRTY CHILDREN WERE RECRUITED TO RECEIVE TITANIUM ELASTIC NAILS AND THE STUDY TOOK PLACE BETWEEN JANUARY 1995 AND FEBRUARY 2004. CHILDREN RECEIVING A TITANIUM ELASTIC NAIL HAD A SHORTER TIME OF HEALING AND WERE ABLE TO PLACE PARTIAL AND FULL WEIGHT-BEARING AND RETURN TO DAILY ACTIVITIES FASTER THAN THE CONVENTIONAL TRACTION AND CAST METHOD. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. ONE PATIENT¿S NAIL MIGRATED; THE TIP WAS CUT OFF IN A NEW SURGERY; ONE PATIENT NEEDED A REVISION DUE TO A FALL; ONE PATIENT HAD SOFT-TISSUE IRRITATION AND HAD THE NAIL REMOVED EARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227884 UNKNOWN - NAIL APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1