BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIIG X3 HI VISC

    MDR report key: 913112 · Received September 14, 2007

    Report

    Report Number
    1043534-2007-00137
    Event Type
    Death
    Date Received
    September 14, 2007
    Date of Event
    August 7, 2007
    Report Date
    August 14, 2007
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MQV
    PMA / PMN Number
    K024336
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETED. THIS EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY, THERE WAS A SPINAL CASE WITH BOXES OF MIIG X3 HI VISC. THE PATIENT DIED DURING THE OPERATION IN THE OR. THE REASON FOR DEATH HAS NOT BEEN CLARIFIED BY SURGEONS DUE TO NOT MAKING ANATOMY OF THE CADAVER. THE ESTIMATE REASON WAS MIOCARDIAL INFARCTION. THE PATIENT WAS HOSPITALIZED AFTER SEVERE LOW BACK PAIN AND NO-ACTIVITY, BECAUSE OF THE LOWER BACK INJURY ONE DAY EARLIER. WITH X-RAY, CT AND MRI, HER DIAGNOSIS WAS L1-3 COMPRESSION FRACTURE. PERFECTING THE PREOPERATIVE EXAMINATION, IN THE MORNING OF ORIGINAL DATE, THE OPERATION WAS TO BEGIN AT 10:30AM. ANESTHESIA DOWNLINK OPEN REDUCTION AND POSTERIOR SPINAL PEDICLE SCREW FIXATION + INJECTABLE CALCIUM SULFATE MATERIAL (MIIGX3 HIVCS) WITHIN FILLING DAMAGED VERTEBRAL BONE. DURING THE OPERATION THE PATIENT APPEARED CARDIAC ARREST, RESPIRATORY ARREST, AND ACTIVE RESCUE INVALID. THE PATIENT PRONOUNCED DEAD AT 12:30 NOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIIG X3 HI VISC MQV WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death