BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3782124 · Received April 30, 2014

    Report

    Report Number
    2520274-2014-11030
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 16, 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. ZHU, Y., MD, LU, Y., MD, SHEN, J., MD, ZHANG, J., MD, AND JIANG, C., MD, PHD (2011). LOCKING INTRAMEDULLARY NAILS AND LOCKING PLATES IN THE TREATMENT OF TWO-PART PROXIMAL HUMERAL SURGICAL NECK FRACTURES. J BONE JOINT SURG AM, 93, 159-168. 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, ZHU, Y., MD, LU, Y., MD, SHEN, J., MD, ZHANG, J., MD, AND JIANG, C., MD, PHD (2011). LOCKING INTRAMEDULLARY NAILS AND LOCKING PLATES IN THE TREATMENT OF TWO-PART PROXIMAL HUMERAL SURGICAL NECK FRACTURES. J BONE JOINT SURG AM, 93, 159-168. THE AUTHORS PERFORMED A PROSPECTIVE RANDOMIZED TRIAL TO COMPARE THE OUTCOMES BETWEEN LOCKING INTRAMEDULLARY NAILS AND LOCKING PLATES IN PATIENTS WITH A TWO-PART SURGICAL NECK FRACTURE. BETWEEN NOVEMBER 2004 AND DECEMBER 2006, TWENTY-FIVE PATIENTS (NINE MALE, 16 FEMALE, AVERAGE AGE 54.8 YEARS) WERE TREATED WITH A SYNTHES PROXIMAL HUMERAL NAIL (PHN) AND 26 PATIENTS (EIGHT MALE, 18 FEMALE, AVERAGE AGE 50.5 YEARS) WERE TREATED WITH A SYNTHES LOCKING PROXIMAL HUMERAL PLATE (LPHP) OR A SYNTHES PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) FOR PROXIMAL HUMERAL FRACTURES. FRACTURE UNION WAS ACHIEVED IN ALL PATIENTS WITHIN THREE MONTHS AFTER SURGERY. NO INFECTION WAS SEEN IN EITHER GROUP. ON FOLLOW-UP, HETEROTOPIC OSSIFICATION WAS FOUND IN ONE PATIENT IN THE LOCKING NAIL GROUP AND TWO PATIENTS IN THE LOCKING PLATE GROUP. THE AUTHORS CONCLUDED THAT SATISFACTORY RESULTS CAN BE ACHIEVED WITH EITHER IMPLANT IN THE TREATMENT OF TWO-PART PROXIMAL HUMERAL SURGICAL NECK FRACTURES. THIS REPORT IS FOR AN UNKNOWN NAIL AND AN UNKNOWN PLATE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260969 NAIL, FIXATION, BONE JDS SYNTHES(USA)

    Patients

    Seq Age Sex Outcome Treatment
    1