BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIIG

    MDR report key: 4792742 · Received May 22, 2015

    Report

    Report Number
    1043534-2015-00025
    Event Type
    Death
    Date Received
    May 22, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 22, 2015
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MQV
    PMA / PMN Number
    K024336
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT COMPLETE. PRODUCT HAS NOT BEEN RETURNED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY, AN INCIDENT OCCURED IN (B)(6), FOR LUMBAR SPONDYLOLISTHESIS, PROTRUSION OF LUMBAR INTERVERTEBRAL DISC., AND OSTEOPOROSIS, THE PATIENT RECEIVE THE SURGERY OF POSTERIOR INTERNAL FIXATION FOR LUMBAR SPINE, AND LUMBAR FUSION ON (B)(6) 2015. THE BONE VOID FILLER PRODUCT WAS USED DURING THE SURGERY, AFTERWARDS, THE PATIENT EXPERIENCED THE ALLERGIC SHOCK SUCH AS BLOOD PRESSURE, OXYGEN SATURATION, ETC., THEN THE PATIENT EXPERIENCE SECONDARY COAGULATION DYSFUNCTION, ALL THESE RESULTING IN PATIENTS WITH MULTIPLE ORGAN FAILURE, AND EVENTUALLY DEATH. SINCE THE CASES OF ILLNESS WAS SEAL UP FOR SAFEKEEPING IN HOSPITAL, WE HAVE NO DETAILED INFORMATION, SUCH AS WHAT OTHER PRODUCTS WAS USED DURING THE SURGERY, SO IT CANNOT BE DETERMINED IF THE DEATH WAS CAUSED BY THE BONE VOID FILLER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334768 MIIG BONE VOID FILLER MQV WRIGHT MEDICAL TECHNOLOGY, INC. 1543905

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death