BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3755101 · Received April 16, 2014

    Report

    Report Number
    2520274-2014-10827
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. KIM, S.-J., MANDAR, A., SONG.-H., & SONG, H.-R. (2011). PITFALLS OF LENGTHENING OVER AN INTRAMEDULLARY NAIL IN TIBIA: A CONSECUTIVE CASE SERIES. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 132, 185-191. THIS REPORT IS FOR AN UNKNOWN AO TIBIAL INTERLOCKING 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. 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. KIM, S.-J., MANDAR, A., SONG.-H., & SONG, H.-R. (2011). PITFALLS OF LENGTHENING OVER AN INTRAMEDULLARY NAIL IN TIBIA: A CONSECUTIVE CASE SERIES. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 132, 185-191. LENGTHENING OVER A NAIL WAS INTRODUCED TO REDUCE THE OVERALL COMPLICATION RATE IN THE CLASSIC ILIZAROV METHOD TO REDUCE THE OVERALL COMPLICATION RATE IN THE CLASSIC PREVIOUS STUDIES REPORTED THAT AN INTRAMEDULLARY NAIL COULD DECREASE THE TIME OF EXTERNAL FIXATION, PREVENT ANATOMIC MALALIGNMENT AND COLLAPSE; INTERNAL FRICTION, DAMAGE TO ENDOSTEAL BLOOD SUPPLY AND INFECTION RATES, HOWEVER, MAY BE HIGHER. WHETHER THE APPROACH ACHIEVES IT GOALS WITH ACCEPTABLE COMPLICATION RATES IS UNCLEAR. THE AIM OF THIS STUDY WAS TO DESCRIBE THE RESULTS AND COMPLICATIONS OF TIBIAL LENGTHENING OVER A NAIL. FORTY PATIENTS WERE REVIEWED WITH 80 LENGTHENED TIBIAL SEGMENTS OVER AN INTRAMEDULLARY NAIL BETWEEN 2004 AND 2009. THE AVERAGE AGE OF THE PATIENTS AT THE TIME OF SURGERY WAS 22 YEARS (RANGE 18¿38 YEARS). FUNCTIONAL AND PSYCHOLOGICAL OUTCOMES WERE EVALUATED USING THE QUESTIONNAIRES. THE AVERAGE LENGTHENING ACHIEVED WAS 7.73 CM, 23.5% OF INITIAL LENGTH. THE EXTERNAL FIXATION INDEX WAS 1.1 MONTHS/CM, AND BONE-HEALING INDEX WAS 1.7 MONTH/CM. THE MOST COMMON COMPLICATIONS WERE VALGUS ANGULATIONS OF TIBIA IN 20 SEGMENTS (25%) AND EQUINUS CONTRACTURE IN 58 SEGMENTS (72%). LENGTHENING OVER A NAIL DID NOT FULLY PREVENT AXIAL DEVIATION OF REGENERATE. EQUINUS CONTRACTURE WAS THE MOST COMMON COMPLICATION BUT IT COULD BE RECTIFIED BY EARLY INTERVENTION SUCH AS INTRAMUSCULAR RECESSION OR AN ADDITIONAL FOOT FRAME. LIMB LENGTHENING INCREASED FUNCTIONAL AND PSYCHOLOGICAL OUTCOMES EVEN THOUGH THERE WERE MANY COMPLICATIONS AFTER SURGERY. ADVERSE EVENTS INCLUDED ONE CASE OF REFRACTURE AND THE INTRAMEDULLARY NAIL WAS REMOVED TO CONTROL DEEP INFECTION. DEEP INFECTIONS OCCURRED DURING DISTRACTION OR EARLY CONSOLIDATION AND WERE TREATED WITH IMPLANT REMOVAL, DEBRIDEMENT AND BONE GRAFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231585 NAIL, FIXATION, BONE JDS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention