BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCREW

    MDR report key: 2768033 · Received September 27, 2012

    Report

    Report Number
    2520274-2012-02034
    Event Type
    Death
    Date Received
    September 27, 2012
    Report Date
    August 30, 2012
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    E: ET. AL: GERSON MAST, MD, DDS, MICHAEL ERMER, MD, DDS, RALF GUTWALD, MD, DDS, RAINER SCHMELZEISEN, MD, DDS, CHRISTOPH PAUTKE, MD, DDS, SVEN OTTO, MD, DDS, SEBASTIAN SCHIEL, MD, DDS, MICHAEL EHRENFIELD, MD, DDS, CARL-PETER CORNELIUS, MD, DDS, AND MARC CHRISTIAN METZGER, MD, DDS. W/O 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 REC'D.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REC'D: SURGICAL ONCOLOGY AND RECONSTRUCTION: MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES - A TWO YR TWO INSTITUTION EXPERIENCE IN 71 PTS REPORTED: A STUDY WAS CONDUCTED FOR 71 SUBJECTS WITH INDICATION FOR A LOAD BEARING OSTEONECROSIS OF THE MANDIBLE. INDICATIONS FOR THE PLATE WERE DEFECTS DUE TO TUMOR, TRAUMA OR OSTEONECROSIS. THE MEAN AGE WAS 54.8 +/- 15.0 YRS INCLUDING 43 MEN WITH MATRIX MANDIBLE PLATES PLACED IN 70 OF 71 PTS. THE F/U PERIOD RANGED FROM 3 TO 26 MONTHS. OF THE 70 PTS 8 DIED. OF THESE PTS 1, 2, 3, AND 2 DIED 3, 5, 6, AND 9 MONTHS POSTOPERATIVELY, RESPECTIVELY. CONCLUSIONS OF STUDY: RESULTS OF STUDY SUGGEST THE USE OF MATRIXMANDIBLE PLATES COINCIDES WITH A REDUCED OPERATIVE TIME AND MINIMIZED RISK OF FATIGUE FRACTURES. THIS REPORT IS ON THE DEATH AT POST OPERATIVE IMPLANTATION AT 9 MONTHS. NO CAUSE OF DEATH WAS LISTED. THIS IS 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW JEY

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R SCREW| PLATE