BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3875978 · Received June 17, 2014

    Report

    Report Number
    2520274-2014-11860
    Event Type
    Injury
    Date Received
    June 17, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FLINKKILA, T., MD, PHD, TOIMELA, J. BM, SIRNIO, K., MD, LEPPILAHTI, J., MD, PHD (2014). RESULTS OF PARALLEL PLATE FIXATION OF COMMINUTED INTRA-ARTICULAR DISTAL HUMERAL FRACTURES. J SHOULDER ELBOW SURG, 23, 701-707. THIS REPORT IS FOR AN UNKNOWN NAIL. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. DEVICE WAS 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, FLINKKILA, T., MD, PHD, TOIMELA, J. BM, SIRNIO, K., MD, LEPPILAHTI, J., MD, PHD (2014). RESULTS OF PARALLEL PLATE FIXATION OF COMMINUTED INTRA-ARTICULAR DISTAL HUMERAL FRACTURES. J SHOULDER ELBOW SURG, 23, 701-707. THE AUTHORS CONDUCTED A RETROSPECTIVE STUDY OF 47 PATIENTS (30 WOMEN, 17 MEN, MEAN AGE 60 YEARS) WITH COMMINUTED DISTAL HUMERAL FRACTURES TREATED WITH PARALLEL PLATE FIXATION BETWEEN 2007 AND 2011. PARALLEL PLATING WITH A COMPETITOR¿S PLATES WAS USED IN ALL CASES. OLECRANON OSTEOTOMY WAS PERFORMED IN 36 PATIENTS. A SYNTHES OLECRANON OSTEOTOMY NAIL WAS USED IN TWO CASES AND WAS ATTEMPTED IN ONE ADDITIONAL PATIENT; HOWEVER, IT FAILED TO COMPRESS THE OSTEOTOMY, AND A POSTERIOR PLATE WAS USED INSTEAD. THE AUTHORS CONCLUDED THAT PARALLEL PLATE FIXATION IS AN EFFECTIVE METHOD TO TREAT COMMINUTED DISTAL HUMERAL FRACTURES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN OLECRANON OSTEOTOMY NAIL. THIS COMPLAINT INVOLVES ONE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355683 NAIL, FIXATION, BONE JDS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention