BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2014-00718

    MDR report key: 3639886 · Received February 21, 2014

    Report

    Report Number
    2520274-2014-00718
    Event Type
    Injury
    Date Received
    February 21, 2014
    Report Date
    January 24, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THIS REPORT IS ON UNKNOWN PHILOS PLATE, PART AND LOT NUMBERS ARE UNKNOWN. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: MONOAXIAL VERSUS POLYAXIAL SCREW INSERTION IN ANGULAR STABLE PLATE FIXATION OF PROXIMAL HUMERAL FRACTURES: RADIOGRAPHIC ANALYSIS OF A PROSPECTIVE RANDOMIZED STUDY; BEN OCKERT, MD, VOLKER BRAUNSTEIN, MD, CHLODWIG KIRCHHOFF, MD, MARKUS KORNER, MD, SONJA KIRCHHOFF, MD, KATHARINA KEHR, MD, WOLF MUTSCHLER, MD, AND PETER BIBERTHALER, MD; THE JOURNAL OF TRAUMA INJURY, INFECTION, AND CRITICAL CARE, VOLUME 69, NUMBER 6, DECEMBER 2010; 1545-1551; REPORTED: A PROSPECTIVE RANDOMIZED STUDY OF TREATMENT WITH MONOAXIAL ANGULAR STABLE PLATE FIXATION, SYNTHES DEVICE PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS), OR POLYAXIAL SCREW INSERTION DEVICE OF A COMPETITOR, IN DISPLACED PROXIMAL HUMERAL FRACTURES. BETWEEN 2006 AND 2008, 66 PATIENTS (48 WOMEN, AND 18 MEN), WITH A MEAN AGE 67.7 YEARS, WERE STUDIED. RESULTS FOR THE PHILOS TREATMENT GROUP INCLUDED: 11 PATIENTS WITH SECONDARY VARUS DISPLACEMENT OF GREATER THAN 10 DEGREE ANGLE AND FOUR CASES OF INTRA-ARTICULAR CUT OUT OF SCREWS WITH SUBSEQUENT HARDWARE REMOVAL. IN ADDITION, ONE CASE OF NONUNION DUE TO OSTEONECROSIS WAS REPORTED (DEVICE INVOLVED WAS NOT SPECIFIED). THE AUTHORS REPORTED THEY FOUND NO RELATIONSHIP BETWEEN MONOAXIAL AND POLYAXIAL SCREW INSERTION REGARDING OCCURRENCE OF SECONDARY VARUS DISPLACEMENT OR SCREW CUT OUT. THEY CONCLUDED THAT MONOAXIAL AND POLYAXIAL SCREW INSERTION ALLOWED FOR MECHANICAL STABILIZATION IN ANGULAR STABLE PLATING OF UNSTABLE PROXIMAL HUMERUS FRACTURES. THIS REPORT IS FOR AN UNKNOWN PHILOS PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110486 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention