BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIIG X3 MINIMALLY INVASIVE INJECTABLE GRAFT

    MDR report key: 638685 · Received September 26, 2005

    Report

    Report Number
    1043534-2005-00114
    Event Type
    Death
    Date Received
    September 26, 2005
    Date of Event
    June 7, 2005
    Report Date
    August 24, 2005
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MQV
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A KYPHOPLASTY, WHICH IS OFF-LABEL USE, IN 2005. PATIENT'S INDICATION WAS SPINAL COMPRESSION FRACTURE TO T11, T12, L1, AND L2. SURGEON INJECTED 4 UNITS OF MIIG X3 AND PATENT DIED 3 HOURS AFTER SURGERY. NO INFORMATION ON OTHER PRODUCTS USED DURING THE PROCEDURE. THE PATIENT'S CONDITION WAS VERY BAD DURING THE PROCEDURE. THE HOSPITAL/DOCTOR SAYS THAT IT IS UNLIKELY THAT MIIG X3 IS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIIG X3 MINIMALLY INVASIVE INJECTABLE GRAFT BIOLOGIC COMPONENT MQV WRIGHT MEDICAL TECHNOLOGY, INC. NA 01465592

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death