BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL

    MDR report key: 5660478 · Received May 17, 2016

    Report

    Report Number
    2520274-2016-12630
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    September 15, 2007
    Report Date
    April 20, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: SANGKAEW, C., (2008). DISTRACTION OSTEOGENESIS OF THE FEMUR USING CONVENTIONAL MONOLATERAL EXTERNAL FIXATOR. ARCH ORTHOP TRAUMA SURG, 128: 889-899. THIS REPORT IS FOR AN UNKNOWN EXFIX (AO/ASIF EXTERNAL FIXATOR), /UNKNOWN QUANTITY/UNKNOWN LOT. PART NUMBER UNKNOWN: UDI UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE PROVIDED. 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 ARTICLE: SANGKAEW, C., (2008). DISTRACTION OSTEOGENESIS OF THE FEMUR USING CONVENTIONAL MONOLATERAL EXTERNAL FIXATOR. ARCH ORTHOP TRAUMA SURG, 128: 889-899. THAILAND. THE PRESENT STUDY EVALUATED A NEW TECHNIQUE OF FEMORAL LENGTHENING, AND ALSO TO EVALUATE THE EFFECT OF PREOPERATIVE AND INTRAOPERATIVE VARIABLES ON THE OUTCOME OF DISTRACTION OSTEOGENESIS IN GENERAL. BETWEEN FEBRUARY 1994 AND NOVEMBER 2005, 51 FEMORA IN 50 PATIENTS (15 FEMALES AND 35 MALES) WERE LENGTHENED. LEG-LENGTH DISCREPANCY WAS THE PRIMARY INDICATION FOR IN ALL PATIENTS. THE MEAN AGE OF THE PATIENTS AT THE TIME OF THE SURGERY WAS 21.9 YEARS (RANGE 5¿48 YEARS). ELEVEN FEMORA WERE IN PATIENTS WHO WERE LESS THAN 14 YEARS OLD (RANGE 5¿13-YEAR OLD), AND 40 IN PATIENTS WHO WERE AGED 14-YEARS OR MORE (RANGE 14¿48-YEAR OLD). THE AVERAGE FOLLOW-UP WAS 24.6 MONTHS AFTER REMOVAL OF THE FIXATOR (RANGE 6¿120 MONTHS). ALL LENGTHENINGS WERE PERFORMED USING CONVENTIONAL AO/ASIF EXTERNAL FIXATOR (SYNTHES). COMPLICATION: FEMUR 43 - (B)(6), MALE, DIAGNOSIS OF POST TRAUMATIC, DEVELOPED NON-UNION. THIS REPORT IS 22 OF 27 FOR (B)(4). THIS REPORT IS FOR UNKNOWN EXFIX (AO/ASIF EXTERNAL FIXATOR), UNKNOWN QUANTITY AND LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316149 APPLIANCE, FIXATION, NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention