BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3759719 · Received April 18, 2014

    Report

    Report Number
    2520274-2014-10839
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS.ADDITIONAL NARRATIVE:¿INTERVENTIONS FOR TREATING PROXIMAL HUMERAL FRACTURES IN ADULTS (REVIEW)¿ HANDOLL, HHG, OLLIVER, BJ, AND ROLLINS, KE (2012). THE COCHRANE LIBRARY (ISSUE 12).THIS REPORT IS FOR UNKNOWN PHILOS PLATES/UNKNOWN LOTS.WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BECOMPLETED; 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, ¿INTERVENTIONS FOR TREATING PROXIMAL HUMERAL FRACTURES IN ADULTS (REVIEW)¿ HANDOLL, HHG, OLLIVER, BJ, AND ROLLINS, KE (2012). THE COCHRANE LIBRARY (ISSUE 12). THE AUTHORS SEARCHED THE COCHRANE BONE, JOINT AND MUSCLE TRAUMA GROUP SPECIALISED REGISTER, THE (B)(6) AND OTHER DATABASES, AND BIBLIOGRAPHIES OF TRIAL REPORTS. THE FULL SEARCH ENDED IN JANUARY 2012. THIS ARTICLE SUMMARIZES POSTOPERATIVE FINDINGS FROM TWENTY-THREE SMALL RANDOMISED TRIALS WITH A TOTAL OF 1238 PARTICIPANTS INCLUDED. ONE RETROSPECTIVE STUDY WAS PERFORMED IN (B)(6) ((B)(6), 2010). PERIOD OF STUDY RECRUITMENT: AUGUST 2006 TO JULY 2008. 76 PATIENTS, AGED OVER 18 YEARS, WITH DISPLACED PROXIMAL HUMERAL FRACTURES WITH DISPLACEMENT > 1 CM AND ANGULATION OF FRAGMENTS > 45 DEGREES (NEER CRITERIA) EXCLUSION CRITERIA: POLY-TRAUMATISED PATIENTS, NEUROLOGIC DEFICIT OR INTRA-OPERATIVE CONVERSION TO SHOULDER ARTHROPLASTY. (PAPER NOTED THERE WERE NO OPEN OR PATHOLOGICAL FRACTURES.) OF 66 PATIENTS: 48 FEMALE, 18 MALE; MEAN AGE 68 YEARS, RANGE 29 TO 92 YEARS. THE PATIENTS UNDERWENT MONOAXIAL ANGULAR STABLE PLATE FIXATION WITH PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) SYNTHES (B)(4). FOUR PATIENTS EXPERIENCED CUT-OUT (INTRA-ARTICULAR). IT WAS REPORTED THAT SOME OF THE PATIENTS UNDERWENT REVISION SURGERY AND EARLY HARDWARE REMOVAL (REASON FOR REVISION NOT REPORTED). IT WAS CONCLUDED THAT THERE WAS INSUFFICIENT EVIDENCE TO ESTABLISH WHAT IS THE BEST METHOD OF SURGICAL TREATMENT, EITHER IN TERMS OF THE USE OF DIFFERENT CATEGORIES OF SURGICAL INTERVENTION (SUCH AS PLATE VERSUS NAIL FIXATION, OR HEMIARTHROPLASTY VERSUS TENSION-WIRE FIXATION) OR DIFFERENT METHODS OF PERFORMING AN INTERVENTION IN THE SAME CATEGORY (SUCH AS DIFFERENT METHODS OF PLATE FIXATION). THERE IS INSUFFICIENT EVIDENCE TO SAY WHEN TO START MOBILISATION AFTER EITHER SURGICAL FIXATION OR HEMIARTHROPLASTY. THIS IS REPORT 1 OF 1 FOR (B)(4). THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS REPORT IS FOR AN UNKNOWN PHILOS WHICH INCLUDES PLATES AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237306 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention