BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, BONE

    MDR report key: 4669786 · Received April 8, 2015

    Report

    Report Number
    2520274-2015-12606
    Event Type
    Injury
    Date Received
    April 8, 2015
    Report Date
    March 24, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USE FOR TREATMENT, NOT DIAGNOSIS. COMPARISON OF TITANIUM AND BIODEGRADABLE MINIPLATES FOR FIXATION OF MANDIBULAR FRACTURES, HYO-BIN LEE, DDS, MSD, JI-SU OH, DDS, MSD, SU-GWAN KIM, DDS, PHD, HAK-KYUN KIM, DDS, PHD, SEONG-YONG MOON, DDS, YOUNG-KYUN KIM, DDS, PHD, PIL-YOUNG YUN, DDS, PHD, AND JUN-SIK SON, PHD. AMERICAN ASSOCIATION OF ORAL AND MAXILLOFACIAL SURGEONS, J ORAL MAXILLOFAC SURG 68:2065-2069, 2010. THIS REPORT IS FOR UNKNOWN PLATE- MINI, QUANTITY AND LOT NUMBER. 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. 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, "COMPARISON OF TITANIUM AND BIODEGRADABLE MINIPLATES FOR FIXATION OF MANDIBULAR FRACTURES" HYO-BIN LEE, DDS, MSD, JI-SU OH, DDS, MSD, SU-GWAN KIM, DDS, PHD, HAK-KYUN KIM, DDS, PHD, SEONG-YONG MOON, DDS, YOUNG-KYUN KIM, DDS, PHD, PIL-YOUNG YUN, DDS, PHD, AND JUN-SIK SON, PHD. AMERICAN ASSOCIATION OF ORAL AND MAXILLOFACIAL SURGEONS, J ORAL MAXILLOFAC SURG 68:2065-2069, 2010. A STUDY WAS CONDUCTED TO COMPARE THE USE OF BIODEGRADABLE MINIPLATES AND TITANIUM MINIPLATES FOR FIXATION OF MANDIBULAR FRACTURES. BIOSORB FX BIODEGRADABLE PLATES AND SCREWS AND TITANIUM MINIPLATES WERE USED IN 91 PATIENTS (65 MALES AND 26 FEMALES; AGE RANGE 11 TO 69 YEARS) FOR THE TREATMENT OF MANDIBULAR FRACTURES. THE CLINICAL AND RADIOGRAPHIC FINDINGS WERE RECORDED AT 1, 3, 6, AND 12 MONTHS AFTER SURGERY. IN THE TITANIUM PLATE GROUP, INFECTION OCCURRED IN 1 CASE AND A PLATE FRACTURE IN 1 CASE. THE FRACTURED PLATE WAS REMOVED, AND A NEW TITANIUM MINIPLATE WAS APPLIED USING A TROCAR. THE INFECTION WAS RESOLVED WITH ANTIBIOTICS. NO ADVERSE TISSUE REACTIONS, MALOCCLUSIONS, OR MALUNIONS OCCURRED DURING THE OBSERVATION PERIOD. THE RESULTS HAVE SHOWN THAT THE RATE OF MORBIDITY IS VERY LOW WITH THE USE OF BIODEGRADABLE PLATES AND TITANIUM PLATES, SUGGESTING THAT BIODEGRADABLE AND TITANIUM PLATES HAVE THE POTENTIAL FOR SUCCESSFUL USE IN THE FIXATION OF MANDIBULAR FRACTURES. THIS IS REPORT IS FOR REPORTABLE MALFUNCTION DESCRIBED AS PLATE FRACTURE. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN PLATES- MINI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231848 PLATE, BONE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention