BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4347409 · Received December 19, 2014

    Report

    Report Number
    2520274-2014-15507
    Event Type
    Injury
    Date Received
    December 19, 2014
    Report Date
    December 3, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS MEAN AGE OF PATIENTS IS 61.2 YEARS. THE STUDY INCLUDED 38 MALE AND 28 FEMALE PATIENTS. VOSS, P.J. ET AL. (2011) STANDARDIZED THREE DIMENSIONALLY PREFORMED MANDIBLE RECONSTRUCTION PLATES: PRELIMINARY CLINICAL EXPERIENCE. INTERNATIONAL JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY, 40 (10), 1044. THIS REPORT IS FOR AN UNKNOWN MATRIX MANDIBLE PLATE/UNKNOWN QUANTITY/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 ABSTRACT, "STANDARDIZED THREE DIMENSIONALLY PREFORMED MANDIBLE RECONSTRUCTION PLATES: PRELIMINARY CLINICAL EXPERIENCE: (2011). VOSS, P.J. ET AL. (2011) STANDARDIZED THREE DIMENSIONALLY PREFORMED MANDIBLE RECONSTRUCTION PLATES: PRELIMINARY CLINICAL EXPERIENCE. INTERNATIONAL JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY, 40 (10), 1044. A RETROSPECTIVE STUDY WAS DONE ON THE CLINICAL PERFORMANCE OF THREE DIMENSIONALLY PREFORMED SYNTHES MATRIX MANDIBLE RECONSTRUCTION AND THE RESULTS PRESENTED AT THE INTERNATIONAL CONFERENCE ON ORAL AND MAXILLOFACIAL SURGERY. THE STUDY INCLUDED 38 MALE AND 28 FEMALE PATIENTS WITH A MEAN AGE OF 61.2 YEARS. THE MEAN OBSERVATION TIME WAS 8.7 MONTHS AFTER PLATE INSERTION. ONE CASE DEVELOPED A NECROSIS AND INFECTION WHICH REQUIRED THE PLATE TO BE REMOVED AND THREE CASES REQUIRED PLATES TO BE REMOVED DUE TO INFECTION OR PLATE EXPOSURE. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT FOR AN UNKNOWN MATRIX MANDIBLE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836257 PLATE, FIXATION, BONE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention