BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4356171 · Received December 23, 2014

    Report

    Report Number
    2520274-2014-15505
    Event Type
    Injury
    Date Received
    December 23, 2014
    Date of Event
    June 11, 2013
    Report Date
    December 3, 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. "SCALP NECROSIS FOLLOWING PEROPERATIVE EMBOLIZATION FOR MENINGEAL TUMORS: TWO CAUTIONARY TALES" (2013). KIRKMAN, M.A., SETHI, H., & KITCHEN, N.D. ACTA NEUROCHIR, 15, 1413-1415. THIS REPORT IS FOR AN UNKNOWN MATRIXNEURO 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, "SCALP NECROSIS FOLLOWING PEROPERATIVE EMBOLIZATION FOR MENINGEAL TUMORS: TWO CAUTIONARY TALES" (2013). KIRKMAN, M.A., SETHI, H., & KITCHEN, N.D. ACTA NEUROCHIR, 15, 1413-1415. A REPORT WAS DONE ON PREOPERATIVE EMBOLIZATION FOR MENINGEAL TUMORS. IN THE REPORT A 58 YEAR OLD FEMALE DEVELOPED NECROSIS AFTER A CRANIOTOMY THAT HEALED POORLY AND HAD SEROUS DISCHARGE FOR SEVERAL MONTHS. IN TWO AREAS OF THE NECROSIS THERE WAS A SYNTHES MATRIXNEURO PLATE AND SCREW PROTRUDING POSTERIORLY AND A SYNTHES MATRIXNEURO SCREW PROTRUDING ANTERIORLY. THE SYNTHES MATRIXNEURO PLATE AND SCREWS WERE SUBSEQUENTLY EXPLANTED. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR 1 UNKNOWN MATRIX NEURO PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847070 PLATE, FIXATION, BONE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention