BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3884928 · Received June 19, 2014

    Report

    Report Number
    2520274-2014-12016
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. YE, T., ET AL. (2013, JUNE) FUNCTIONAL OUTCOMES FOLLOWING LOCKING PLATE FIXATION OF COMPLEX PROXIMAL HUMERAL FRACTURES. ORTHOPEDICS, 36, E715 - E722. (B)(6). THIS REPORT IS FOR AN UNKNOWN PLATE. 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: FUNCTIONAL OUTCOMES FOLLOWING LOCKING PLATE FIXATION OF COMPLEX PROXIMAL HUMERAL FRACTURES. YE, T., ET AL. (2013, JUNE). FUNCTIONAL OUTCOMES FOLLOWING LOCKING PLATE FIXATION OF COMPLEX PROXIMAL HUMERAL FRACTURES. ORTHOPEDICS, 36, E715 - E722. THIS WAS A RETROSPECTIVE REVIEW OF 237 PATIENTS WITH PROXIMAL HUMERAL FRACTURES WHO UNDERWENT LOCKING PLATE FIXATION BETWEEN MAY 2007 AND DECEMBER 2010. EIGHTY-NINE PATIENTS (27 MEN, 62 WOMEN) OLDER THAN 50 YEARS WITH THREE AND FOUR PART FRACTURES WERE INCLUDED. ALL PATIENTS WERE FOLLOWED UP FOR MORE THAN ONE YEAR. THE COMPLICATIONS WERE EVALUATED THROUGH PHYSICAL AND RADIOGRAPHIC EXAMINATIONS. EIGHTEEN PATIENTS EXPERIENCED COMPLICATIONS WHICH INCLUDED SUBACROMIAL EIGHT IMPINGEMENTS, THREE SCREW CUT-OUTS, TWO MALUNIONS, TWO TUBEROSITY RESORPTIONS, TWO INCIDENCES OF AVASCULAR NECROSES OF THE HUMERAL HEAD, AND ONE SCREW BREAKAGE. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE FUNCTIONAL SHOULDERS OUTCOMES AFTER LOCKING PLATE FIXATION OF DISPLACED THREE AND FOUR PART PROXIMAL HUMERAL FRACTURES IN ELDERLY CHINESE PATIENTS. THE AUTHORS REPORTED EIGHT SUBACROMIAL IMPINGEMENTS, TWO TUBEROSITY RESORPTIONS, AND TWO INCIDENCES OF AVASCULAR NECROSES OF THE HUMERAL HEAD AND THREE SCREW CUT-OUTS, TWO MALUNIONS, AND ONE SCREW BREAKAGE. THIS IS A REPORTABLE MALFUNCTION REPORT FOR THREE SCREW CUT-OUTS, TWO MALUNIONS, AND ONE SCREW BREAKAGE. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359773 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1