BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRANIOPLASTIC TYPE 1 SLOW SET

    MDR report key: 308355 · Received December 8, 2000

    Report

    Report Number
    308355
    Event Type
    Death
    Date Received
    December 8, 2000
    Date of Event
    December 5, 2000
    Report Date
    December 8, 2000
    Manufacturer
    CODMAN J & J
    Product Code
    GXP
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANAPHYLAXIS SECONDARY TO INTRAVERTEBRAL INJECTION OF CRANIOPLASTIC (LIQUID METHYL METHACRYLATE OR ISOVUE M-300 DYE). THE PT WAS RECEIVING A FLUOROSCOPICALLY GUIDED LUMBAR VERTEBROPLASTY OF THE L1-L2 VERTEBRAL BODIES FOR THE TREATMENT OF COMPRESSION FRACTURES. ISOVUE M-300 DYE WAS USED PRIOR TO CRANIOPLASTIC INJECTION AS PART OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRANIOPLASTIC TYPE 1 SLOW SET RESINOUS MATERIAL GXP CODMAN J & J NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death