BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3759663 · Received April 18, 2014

    Report

    Report Number
    2520274-2014-10833
    Event Type
    Malfunction
    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. HANDOLL, HHG, OLLIVER, BJ, AND ROLLINS, KE (2012). ¿INTERVENTIONS FOR TREATING PROXIMAL HUMERAL FRACTURES IN ADULTS (REVIEW)¿ THE COCHRANE LIBRARY (ISSUE 12). THIS REPORT IS FOR UNKNOWN PHILOS PLATES/UNKNOWN LOT. 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, ¿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 COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS, MEDLINE, EMBASE 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 SWEDEN (OLERUD, 2010). PERIOD OF STUDY RECRUITMENT: PERIOD OF STUDY RECRUITMENT: APRIL 2003 TO MARCH 2008 60 PATIENTS WITH AN ACUTE DISPLACED (BASED ON NEER¿S CRITERIA) 3-PART PROXIMAL HUMERAL FRACTURES (ALL HAD DISPLACED SURGICAL NECK FRACTURE, ALL BAR ONE HAD A DISPLACED GREATER TUBEROSITY; THE EXCEPTION HAD A DISPLACED LESSER TUBEROSITY). 48 FEMALE, 11 MALE; MEAN AGE 74 YEARS (1 PATIENT EXCLUDED THEMSELVES), RANGE 56 TO 92 YEARS (OPERATIONS WERE PERFORMED WITHIN A MEAN OF 6 DAYS AFTER THE INJURY). SURGERY: OPERATION OCCURRED AT MEAN OF 6.1 DAYS OF INJURY. OPEN REDUCTION AND FIXATION USING A DELTOPECTORAL APPROACH WITH A PHILOS PLATE (SYNTHES, (B)(4)) AND WITH NONABSORBABLE SUTURES USED TO FIX DISPLACED / UNSTABLE LESSER AND/OR GREATER TUBEROSITY FRACTURES. THREE PATIENTS EXPERIENCED AVASCULAR NECROSIS, SOME OF WHICH REQUIRED IMPLANT REMOVAL. TWO PATIENTS EXPERIENCED INFECTION REQUIRING SURGERY. ONE PATIENT EXPERIENCED NON-UNION REQUIRING SURGERY. EIGHT PATIENTS EXPERIENCED SCREW PENETRATION INTO THE JOINT, WHICH REQUIRED REVISION SURGERY. 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. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS REPORT IS FOR UNKNOWN PHILOS PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236934 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention