BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIIG® INJECTABLE GRAFT

    MDR report key: 8292385 · Received January 31, 2019

    Report

    Report Number
    1043534-2019-00007
    Event Type
    Death
    Date Received
    January 31, 2019
    Date of Event
    September 28, 2018
    Report Date
    January 2, 2019
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY, THE PATIENT RECEIVED BONE POWDER PLACEMENT DUE TO VERTEBRAL COMPRESSION FRACTURE IN THE HOSPITAL. THE BONE POWDER PLACEMENT WAS PERFORMED FOR COMPRESSION FRACTURE OF THE SECOND LUMBAR VERTEBRA UNDER LOCAL ANESTHESIA AT 15:00 ON DATE OF SURGERY. THE PATIENT LAY ON THE SIDE ON THE OPERATING TABLE, WITH CHEST AND ABDOMEN BEING PROTECTED BY THE SOFT PILLOW. THE NEEDLE INSERTION POINT AT RIGHT ARCH PEDICLE OF THE SECOND LUMBAR VERTEBRA WAS DETERMINED UNDER GUIDANCE OF THE C-ARM. WHEN THE DRAPE HAD BEEN ROUTINELY DISINFECTED AND SATISFACTORY LOCAL INFILTRATION ANAESTHESIA WAS ACHIEVED WITH 5 ML OF 0.5% LIDOCAINE, THE PUNCTURE NEEDLE WAS INSERTED THROUGH THE VERTEBRAL PEDICLE UNTIL IT REACHED 1/2 OF THE VERTEBRAL PEDICLE UNDER GUIDANCE OF THE C ARM. WHEN THE FRONTAL AND ANTEROPOSTERIOR AND LATERAL VIEWS WERE ACCEPTABLE, 10 MG OF DEXAMETHASONE WAS INJECTED INTRAVENOUSLY, AND 2 ML OF MIXED BONE POWDER WAS INJECTED SLOWLY. AT 16:11, THE PATIENT SHOWED DYSPNEA AND ASTHMATOID BREATHING SUDDENLY. THE PATIENT WAS MADE TO LIE ON THE BACK IMMEDIATELY. CARDIAC AUSCULTATION FOUND NO HEART SOUND. THE DOCTOR SUSPECTED EITHER OF THE FOLLOWING OCCURRED: PULMONARY EMBOLISM, ALLERGY TO BONE POWDER, ACUTE MYOCARDIAL INFARCTION (SUDDEN DEATH), CEREBROVASCULAR ACCIDENT. THE ANESTHETIST PERFORMED TRACHEAL INTUBATION AND EXTERNAL CHEST COMPRESSION IMMEDIATELY AND INJECTED 1MG OF EPINEPHRINE AND 80 MG OF MEPREDNISONE INTRAVENOUSLY. ELECTRIC DEFIBRILLATION WAS REPEATED SEVERAL TIMES, THE EXTERNAL CHEST COMPRESSION WAS PROVIDED CONTINUOUSLY, THE POSITIVE PRESSURE VENTILATION WAS GIVEN, BUT THE HEARTBEAT STILL COULD NOT BE RECOVERED. THE EPINEPHRINE AND ATROPINE WERE INJECTED INTRAVENOUSLY SEVERAL TIMES. THE DOPAMINE AND NORADRENALINE WERE INJECTED THROUGH THE VENOUS PUMP. THE INFUSION SPEED WAS INCREASED. THE CEREBRAL RESUSCITATION WITH ICE CAP THERAPY HELMET WAS PERFORMED. THE PATIENT HAD NO AUTONOMOUS HEARTBEAT AND AUTONOMOUS RESPIRATION AND SHOWED BILATERAL MYDRIASIS, AND CLINICALLY DIED AT 17:55.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86211 MIIG® INJECTABLE GRAFT FILLER, BONE VOID, CALCIUM COMPOUND MQV WRIGHT MEDICAL TECHNOLOGY, INC. 84XSIN05 1566523

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death