BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE

    MDR report key: 4550984 · Received February 26, 2015

    Report

    Report Number
    2520274-2015-10964
    Event Type
    Injury
    Date Received
    February 26, 2015
    Report Date
    February 2, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. "HARDWARE REMOVAL RATES FOR MANDIBULAR ANGLE FRACTURES: COMPARING THE 8-HOLE STRUT AND CHAMPY PLATES" (2013). MOORE, E., BAYRAK, S., MOODY, M., KEY, M., VURAL, E. THE JOURNAL OF CRANIOFACIAL SURGERY & VOLUME 24, NUMBER 1, JANUARY 2013, 163-165. THIS REPORT IS FOR AN UNKNOWN STRUT PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. 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 : "HARDWARE REMOVAL RATES FOR MANDIBULAR ANGLE FRACTURES: COMPARING THE 8-HOLE STRUT AND CHAMPY PLATES" (2013). MOORE, E., BAYRAK, S., MOODY, M., KEY, M., VURAL, E. THE JOURNAL OF CRANIOFACIAL SURGERY & VOLUME 24, NUMBER 1, JANUARY 2013, 163-165. USA ARTICLE. THE GOAL OF THIS STUDY IS TO COMPARE THE REMOVAL RATES OF 8-HOLE ANGLE STRUT PLATE AND CHAMPY LINE PLATE IN REPAIRING MANDIBULAR ANGLE FRACTURES. ONE HUNDRED FOUR PATIENTS WITH A TOTAL OF 106 ANGLE FRACTURES MET THE INCLUSION CRITERIA FOR THIS STUDY. IN PATIENTS WHO UNDERWENT PLATE REMOVAL, THE CHART WAS REVIEWED FOR THE CAUSE FOR REMOVAL OR REPLACEMENT OF THE PLATE. LOOSE PLATES WERE IDENTIFIED EITHER DURING CLINIC VISITS, IF THE PLATES ARE EXPOSED; OR DURING SURGERY WHEN EXPLORING THE REASON OF PERSISTENT PAIN OR CHRONIC INFECTION. ALL SP WERE SECURED WITH MONOCORTICAL SCREWS PLACED THROUGH A TRANSBUCCAL TROCAR. ALL CP WERE WITH A SINGLE 4- OR 6-HOLE PLATE WITH MONOCORTICAL SCREWS THROUGH A TRANSORAL ROUTE. SIX OF THE 73 (8.2%) ANGLE FRACTURES REPAIRED WITH SP NECESSITATED PLATE REMOVAL. 2 OF 6 PLATES WERE REMOVED DUE TO LOOSE HARDWARE. THE OTHER 4 PLATE REMOVALS IN SP GROUP WERE DUE TO RECURRENT INFECTION (N = 2, 3%), PERSISTENT EXPOSURE (N = 1, 1%), AND PERSISTENT PAIN (N = 1, 1%) IN THE ABSENCE OF LOOSE HARDWARE. 3 OF THE 6 PLATES REMOVED IN THE SP GROUP WERE REPLACED WITH ANOTHER PLATE BECAUSE OF NONUNION. PLATE REMOVAL WAS PERFORMED IN 6 OF THE 33 (18.2%) PATIENTS REPAIRED WITH CP. LOOSE HARDWARE WAS THE REASON OF ALL PLATE REMOVALS IN CP GROUP. ONE OF THE 6 PLATES REMOVED IN THE CP GROUP WAS REPLACED WITH ANOTHER PLATE BECAUSE OF NONUNION. THIS REPORT IS 1 OF 4 FOR (B)(4). THIS REPORT IS FOR UNKNOWN (CMF) 8-HOLE ANGLE STRUT PLATES, UNKNOWN (CMF) CHAMPY LINE PLATES AND UNKNOWN MONOCORTICAL SCREWS. THIS REPORT IS FOR 3 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135417 BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention