BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5007547 · Received August 17, 2015

    Report

    Report Number
    2520274-2015-15244
    Event Type
    Malfunction
    Date Received
    August 17, 2015
    Report Date
    August 4, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANDRADE-SILVA, F.B., MD, PHD, KOJIMA, K.E., MD, PHD, JOERIS, A., MD, SILVA, J.S., MD, PHD, AND MATTAR JR., R., MD, PHD (2015). SINGLE, SUPERIORLY PLACED RECONSTRUCTION PLATE COMPARED WITH FLEXIBLE INTRAMEDULLARY NAILING FOR MIDSHAFT CLAVICULAR FRACTURES. J BONE JOINT SURG AM. 97(8), 620-626. THIS REPORT IS FOR AN UNKNOWN PLATE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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, ANDRADE-SILVA, F.B., MD, PHD, KOJIMA, K.E., MD, PHD, JOERIS, A., MD, SILVA, J.S., MD, PHD, AND MATTAR JR., R., MD, PHD (2015). SINGLE, SUPERIORLY PLACED RECONSTRUCTION PLATE COMPARED WITH FLEXIBLE INTRAMEDULLARY NAILING FOR MIDSHAFT CLAVICULAR FRACTURES. J BONE JOINT SURG AM. 97(8), 620-626. IN THIS PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL, FIFTY-NINE PATIENTS WITH DISPLACED MIDSHAFT CLAVICULAR FRACTURES WERE RANDOMLY ASSIGNED (BETWEEN MAY 2010 AND JANUARY 2013) TO RECEIVE FIXATION WITH EITHER A RECONSTRUCTION PLATE (THIRTY-THREE PATIENTS), KNOWN AS THE PLATE GROUP, OR ELASTIC STABLE INTRAMEDULLARY NAILING (ESIN; TWENTY-SIX PATIENTS), KNOWN AS THE NAIL GROUP. IN THE PLATE GROUP, THE FRACTURE WAS FIXED USING A SYNTHES 3.5-MM NON-LOCKED RECONSTRUCTION PLATE. IN THE NAIL GROUP, ONE SYNTHES TITANIUM ELASTIC NAIL [TEN] WAS INSERTED PER FRACTURE THROUGH THE MEDIAL FRAGMENT. THE NAIL DIAMETERS WERE 2.0, 2.5, OR 3.0 MM. MINOR COMPLICATIONS INCLUDED PARTIAL IMPLANT MIGRATION (WITH NO LOSS OF FIXATION). ONE PATIENT IN THE PLATE GROUP PRESENTED WITH A TOTAL IMPLANT FAILURE, BUT PROGRESSED TO COMPLETE UNION AND SATISFACTORY FUNCTION. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541581 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1