BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3884356 · Received June 19, 2014

    Report

    Report Number
    2520274-2014-11916
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FOR TREATMENT, NOT DIAGNOSIS. INTERNAL FIXATION OF THE FIBULA IN ANKLE FRACTURES. A PROSPECTIVE, RANDOMIZED AND COMPARATIVE STUDY: PLATING VERSUS NAILING. ASLOUM, Y., BEDIN, B., ROGER, T., CHARISSOUX, J.L., ARNAUD, J.-P, MABIT, C. THIS REPORT IS FOR AN UNKNOWN RECONSTRUCTION LOCKING COMPRESSION PLATE /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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, INTERNAL FIXATION OF THE FIBULA IN ANKLE FRACTURES. A PROSPECTIVE, RANDOMIZED AND COMPARATIVE STUDY: PLATING VERSUS NAILING. ASLOUM, Y., BEDIN, B., ROGER, T., CHARISSOUX, J.L., ARNAUD, J.-P, MABIT, C. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 100 (2014) S255-S259. THE AUTHORS CONDUCTED A PROSPECTIVE STUDY OF 71 PATIENTS (37 MALES, 34 FEMALES, MEAN AGE 53 YEARS+19) BETWEEN APRIL 2011 AND JANUARY 2012 TO COMPARE BONE UNION, COMPLICATIONS AND FUNCTIONAL RESULTS OF TWO TYPES OF INTERNAL FIXATION OF THE FIBULA (PLATING AND THE COMPETITORS FH INTRAMEDULLARY NAIL). THIRTY-FIVE PATIENTS WERE RANDOMIZED INTO THE SYNTHES AO RECONSTRUCTION LOCKING COMPRESSION PLATES AND 36 PATIENTS INTO THE COMPETITOR INTRAMEDULLARY NAILS GROUP. HOWEVER, INTRAMEDULLARY NAILING WAS IMPOSSIBLE IN 7 PATIENTS (10%) FOR TECHNICAL REASONS AND WAS CONVERTED IN PLATE FIXATION. THE 7 CONVERTED CASES WERE ANALYZED INDEPENDENTLY. AT ONE-YEAR OF FOLLOW-UP TWO PATIENTS WERE LOST TO FOLLOW-UP AND TWO HAD DIED. THUS RESULTS WERE BASED ON THE ANALYSIS OF PLATE FIXATION IN 32 FRACTURES AND NAILING IN 28 FRACTURES. BONE UNION WAS OBTAINED IN 94% OF THE CASES IN THE ¿PLATE FIXATION¿ GROUP AND 100% OF THE CASES IN THE ¿INTRAMEDULLARY NAILING GROUP. THE FOLLOWING COMPLICATIONS WERE REPORTED: 2 WITH SEPSIS, 2 SECONDARY DISPLACEMENT. AND 5 ALGODYSTROPHY. THE MAIN GOAL OF THIS STUDY WAS TO COMPARE THE RESULT OF BONE UNION WITH TWO TYPES OF INTERNAL FIXATION: THERE WAS NO DIFFERENCE IN THE RATE OF UNION BETWEEN FIBULAR NAILING AND PLATE FIXATION. THIS REPORT IS FOR AN UNKNOWN RECONSTRUCTION LOCKING COMPRESSION PLATE. THIS IS REPORT 1 OF 1 (B)(4). THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS FOR AN UNKNOWN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362092 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention