BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIIG MINIMALLY INVASIVE INJECTABLE GRAFT

    MDR report key: 638505 · Received September 26, 2005

    Report

    Report Number
    1043534-2005-00105
    Event Type
    Death
    Date Received
    September 26, 2005
    Date of Event
    June 3, 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 VERTEBROPLASTY, WHICH IS OFF-LABEL USE, JUNE 2005. PATIENT'S INDICATION IS SPINAL COMPRESSION FRACTURE TO T12, & L2. SURGEON INJECTED 2 UNITS OF MIIG X3 INTO VERTEBRA BODY AND PATIENT DIED 12 HOURS AFTER SURGERY. NO INFORMATION ON OTHER PRODUCTS USED DURING THE PROCEDURE EXCEPT THAT CONTRAST MEDIA WAS USED PRIOR TO MIIG X3 FOR ANGIOGRAPH. THE PATIENT'S CONDITION WAS NOT GOOD, SHOWING A LOW BP DURING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death