BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3676987 · Received March 13, 2014

    Report

    Report Number
    2520274-2014-10246
    Event Type
    Injury
    Date Received
    March 13, 2014
    Report Date
    February 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    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. BABST, R., BRUNNER, A. AND THORMANN, S. (2012). MINIMALLY INVASIVE PERCUTANEOUS PLATING OF PROXIMAL HUMERAL SHAFT FRACTURES WITH THE PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM (PHILOS). J SHOULDER ELBOW SURG, 21, 1056-1063. THIS REPORT IS FOR AN UNKNOWN PROXIMAL HUMERUS INTERNAL LOCKING PLATE. 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: BABST, R., BRUNNER, A. AND THORMANN, S. (2012). MINIMALLY INVASIVE PERCUTANEOUS PLATING OF PROXIMAL HUMERAL SHAFT FRACTURES WITH THE PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM (PHILOS). J SHOULDER ELBOW SURG, 21, 1056-1063. THE AUTHORS STUDIED FIFTEEN PATIENTS (SEVEN MEN AND EIGHT WOMEN) MEDIAN AGE 60 YEARS (RANGE, 40-96 YEARS) WHO UNDERWENT MINIMALLY INVASIVE PERCUTANEOUS PLATING OF UNILATERALLY, DISPLACED PROXIMAL HUMERAL SHAFT FRACTURES WITH SYNTHES PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM (PHILOS). THE PATIENTS WERE TREATED BETWEEN 2005 AND 2008; MEDIAN FOLLOW- UP WAS 27 MONTHS (RANGE, 12-38 MONTHS). THREE PATIENTS UNDERWENT HARDWARE REMOVAL AT 12 MONTHS DUE TO SUB ACROMIAL IMPINGEMENT OF THE PLATE. THE AUTHORS CONCLUDED THAT MINIMALLY INVASIVE PERCUTANEOUS PLATING WITH PHILOS IS A VALUABLE OPTION TO TREAT PROXIMAL HUMERAL SHAFT FRACTURES WITH SIMILAR RATES OF NONUNION AND FEWER INCIDENTS OF RADIAL NEUROPATHY COMPARED WITH OPEN PROCEDURES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN PROXIMAL HUMERUS INTERNAL LOCKING PLATE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149950 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention