BEUDAMED
    FDA Adverse Event Death Summary report: N

    8-HOLE JL PLATE

    MDR report key: 5808935 · Received July 20, 2016

    Report

    Report Number
    0001032347-2016-00352
    Event Type
    Death
    Date Received
    July 20, 2016
    Date of Event
    June 3, 2016
    Report Date
    July 6, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK011076
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DR. (B)(6) IS THE (B)(6). HE PROVIDED THE FOLLOWING CLINICAL ASSESSMENT OF THIS EVENT: "STERNAL DEHISCENCE AND INFECTION IS A COMPLICATION THAT CAN OCCUR AFTER STERNOTOMY FOR MULTIPLE REASONS INCLUDING PATIENT RISK FACTORS SUCH AS DIABETES, OBESITY, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, OSTEOPOROSIS, TOBACCO USE, REOPERATION, PROLONGED INTENSIVE CARE UNIT STAYS, AND STERNAL STABILITY, ETC. WHILE THE INCIDENCE RATE THAT IS TYPICALLY REPORTED IS LOW (GENERALLY 1-5%), THE COMPLICATION CAN CONTRIBUTE TO OR LEAD TO DEATH. THERE IS LIMITED INFORMATION IN THIS COMPLAINT AS TO THE CAUSE OF THE INFECTION AND DEHISCENCE. IT WAS REPORTED THAT THE STERNAL PLATES AND SCREWS WERE FIXATED WHEN THE WOUND OPENED. THIS DOES NOT SUGGEST THAT THERE WAS AN ISSUE WITH THE PERFORMANCE OF THE PRODUCT..." REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. "INFECTION" IS LISTED IN THE "POSSIBLE ADVERSE EFFECTS" SECTION OF THE PACKAGE INSERT. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE PRODUCT WAS DISCARDED BY THE HOSPITAL AND THEREFORE WILL NOT BE RETURNED FOR AN EVALUATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT 4 OF 7 FOR THE SAME EVENT. REPORTS 1, 2, 3, AND 5 THROUGH 7 ARE REPORTED ON MFR #0001032347-2016-00336-1, 0001032347-2016-00337-1, 0001032347-2016-00351, AND 0001032347-2016-00353 THROUGH 0001032347-2016-00355.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STERNOTOMY WAS FOUND OPENED (WOUND DEHISCENCE) WITH FIXATION IN PLACE ON (B)(6) 2016. IT IS REPORTED THE PATIENT DIED AS A RESULT OF AN INFECTION ON (B)(6) 2016. IT IS NOTED THAT THE PATIENT WAS "ALIVE" AT THE TIME OF THE DISCOVERY OF THE WOUND DEHISCENCE. THE INJURY WAS ALSO DESCRIBED AS A "CUTTING." IT IS REPORTED THAT THE DEVICE WAS NOT IN PLACE IN THE PATIENT AT THE TIME OF DEATH AS IT WAS REMOVED ON (B)(6) 2016. IT IS REPORTED THAT SEPTIC SHOCK CAUSED BY MEDIASTINITIS WAS A CIRCUMSTANCE LEADING TO THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463630 8-HOLE JL PLATE BONE PLATE HRS BIOMET MICROFIXATION N/A J172710

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death| H| O| R