BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3768556 · Received April 23, 2014

    Report

    Report Number
    2520274-2014-11018
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    May 22, 2012
    Report Date
    April 1, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REYNOLDS, R. A. A., LEGAKIS, J. E., THOMAS, R., SLONGO, T. F., HUNTER, J. B., CLAVERT, J. (MAY 22, 2012). INTRAMEDULLARY NAILS FOR PEDIATRIC DIAPHYSEAL FEMUR FRACTURES IN OLDER, HEAVIER CHILDREN: EARLY RESULTS. J CHILD ORTHOP 6:181-188. REPORT IS FOR AN UNKNOWN ADOLESCENT LATERAL ENTRY FEMORAL 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: INTRAMEDULLARY NAILS FOR PEDIATRIC DIAPHYSEAL FEMUR FRACTURES IN OLDER, HEAVIER CHILDREN: EARLY RESULTS; REYNOLDS, R. A. A., LEGAKIS, J. E., THOMAS, R., SLONGO, T. F., HUNTER, J. B., CLAVERT, J. (MAY 22, 2012). INTRAMEDULLARY NAILS FOR PEDIATRIC DIAPHYSEAL FEMUR FRACTURES IN OLDER, HEAVIER CHILDREN: EARLY RESULTS. J CHILD ORTHOP 6:181-188. THIS WAS A RETROSPECTIVE COHORT STUDY REVIEWING MEDICAL RECORDS OF 22 CHILDREN AGES 10-17 REQUIRING SURGICAL FIXATION OF A FEMUR FRACTURE FOR A PERIOD OF 2.5 YEARS. SEVEN (7) PATIENTS WERE TREATED WITH ELASTIC STABLE INTRAMEDULLARY NAILS (ESINS) WITHOUT END-CAPS AND 15 PATIENTS WERE TREATED WITH ADOLESCENT LATERAL ENTRY FEMORAL NAILS (ALFNS, SYNTHES). OF THE PATIENTS IN THE ALFN GROUP (DEMOGRAPHICS: AGE RANGE 10-16 YEARS, 11 PERCENT MALE, MEAN WEIGHT 59.6 KG), 46.7 PERCENT EXPERIENCED MINOR COMPLICATIONS SUCH AS PAIN, IMPLANT PAIN, OR IRRITATION. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN ADOLESCENT LATERAL ENTRY FEMORAL NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247702 NAIL, FIXATION, BONE JDS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention