BEUDAMED
    FDA Adverse Event Death Summary report: N

    BONEPLAST BONE VOID FILLER

    MDR report key: 415698 · Received September 10, 2002

    Report

    Report Number
    2029012-2002-00003
    Event Type
    Death
    Date Received
    September 10, 2002
    Date of Event
    August 14, 2002
    Report Date
    September 9, 2002
    Manufacturer
    INTERPORE CROSS INTL.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE INVOLVING T10, 11 AND 12, CDO KITS WERE USED TO DELIVER PMMA BONE CEMENT AND BONEPLAST BONE VOID FILLER. AFTER THE PMMA CEMENT AND BONEPLAST WAS PLACED, THE PT "CODED". THERE WAS A "DON NOT RESUSCITATE" ORDER AND THE PT DECEASED. PHYSICIAN STATED THAT IT WAS A SUBSTANCE COMPLICATION CAUSED BY A TOXIC REACTION BY THE PT TO THE PMMA CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONEPLAST BONE VOID FILLER BONE VOID FILLER MQV INTERPORE CROSS INTL. NA 206704

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death