BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, BONE

    MDR report key: 4220539 · Received November 3, 2014

    Report

    Report Number
    2520274-2014-14429
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. (B)(4). THIS REPORT IS FOR ONE UNKNOWN MANDIBULAR LOCKING PLATE IMPLANT DATE - 21 MONTHS AFTER (B)(6) 2007. EXPLANT: DATE UNKNOWN. 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE REPLACEMENT OF FRACTURED RECONSTRUCTION PLATE WITH CUSTOMIZED MANDIBLE IMPLANT: A NOVEL TECHNIQUE BEDOGNI A., BETTINI G., FERRONATO G., FUSETTI S., SAIA G,. LARYNGOSCOPE, 124:401¿404, FEB 2014. CASE STUDY: A (B)(6) FEMALE PRESENTED TO OUR DEPARTMENT IN (B)(6) 2012 WITH THE SUDDEN ONSET OF PAINFUL CHEEK SWELLING ASSOCIATED WITH SLIGHT MANDIBLE DEFORMITY AND DENTAL MALOCCLUSION. PAST MEDICAL HISTORY REVEALED MULTIPLE MYELOMA DIAGNOSIS IN 2000, HYPERTENSION, AND MILD CHRONIC KIDNEY FAILURE. HER RIGHT MANDIBLE HAD BEEN FIRST RESECTED AND RECONSTRUCTED WITH 2.4-MM TITANIUM LOCKING PLATE (SYNTHES (B)(4)) IN (B)(6) 2007 DUE TO BISPHOSPHONATE-ASSOCIATED OSTEONECROSIS. THE PLATE HAD TO BE ALREADY REPLACED 21 MONTHS LATER DUE TO LOOSENING OF SCREWS AND PLATE DISLOCATION. THE COMPUTED TOMOGRAPHY (CT) CONFIRMED THE RECONSTRUCTION PLATE FRACTURE, WHICH OCCURRED AT THE JUNCTION BETWEEN THE PLATE AND THE NATIVE DISTAL STUMP. THE FRACTURED PLATE WAS SURGICALLY REMOVED THROUGH A RIGHT SUBMANDIBULAR APPROACH AND SUBSTITUTED WITH THE PATIENT SPECIFIC MANDIBLE-LIKE PROTOTYPE. THE PROSTHESIS NICELY FITTED IN THE PLANNED POSITION AND WAS FIXED TO THE MANDIBULAR STUMPS USING BICORTICAL SCREWS. THIS REPORT IS 2 OF 3 FOR (B)(4). THIS REPORT IS FOR ONE UNKNOWN MANDIBULAR LOCKING PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702612 PLATE, BONE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention