BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3760124 · Received April 18, 2014

    Report

    Report Number
    2520274-2014-10855
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Report Date
    April 4, 2014
    Manufacturer
    SYNTHES(USA)
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. OZDEMIR, B., AKESEN, B., DEMIRAG, B., BILGEN, M. S., AND DURAK, K., (2012, MARCH). LONG-TERM OUTCOME OF UNREAMED INTRAMEDULLARY NAILS IN FEMUR DIAPHYSEAL FRACTURES. TURKISH JOURNAL OF TRAUMA AND EMERGENCY SURGERY, 18 (2), 147-152. THIS REPORT IS FOR AN UNKNOWN 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. OZDEMIR, B., AKESEN, B., DEMIRAG, B., BILGEN, M. S., AND DURAK, K., (2012, MARCH). LONG-TERM OUTCOME OF UNREAMED INTRAMEDULLARY NAILS IN FEMUR DIAPHYSEAL FRACTURES. TURKISH JOURNAL OF TRAUMA AND EMERGENCY SURGERY, 18 (2), 147-152. THE AUTHORS CONDUCTED A STUDY OF 25 ADULTS (19 MALE, SIX FEMALE, AVERAGE AGE 31 YEARS) WITH 29 TRAUMATIC FEMUR DIAPHYSEAL FRACTURES WHO HAD UNDERGONE UNREAMED INTRAMEDULLARY NAILING WITH A SYNTHES UNREAMED FEMORAL NAIL BETWEEN JANUARY 1997 AND DECEMBER 2007. ON FOLLOW-UP (MEAN FOLLOW-UP TIME WAS 65 MONTHS), THERE WAS NON-UNION IN ONE (B)(6)-YEAR-OLD MALE WHICH WAS TREATED BY REAMED INTRAMEDULLARY NAIL AND AUTOGRAFT FROM THE ILIAC CREST. TWO PATIENTS EXPERIENCED MALUNION. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN FEMORAL NAIL. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237362 NAIL, FIXATION, BONE JDS SYNTHES(USA)

    Patients

    Seq Age Sex Outcome Treatment
    1