BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRANIOPLASTIC KIT

    MDR report key: 496118 · Received November 18, 2003

    Report

    Report Number
    1226348-2003-00263
    Event Type
    Death
    Date Received
    November 18, 2003
    Date of Event
    October 17, 2001
    Report Date
    October 30, 2003
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GXP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PLAINTIFF'S ATTY REPORTS THAT THE PT UNDERWENT SURGICAL PROCEDURES ON THORACIC VERTEBRAE. CLAIMS CRANIOPLASTIC KIT WAS INJECTED DURING VERTEBROPLASTY IN 2001. THE ATTY CLAIMS THE CRANIOPLASTIC KIT WAS USED INAPROPRIATELY RESULTING IN PT'S DEATH ALMOST TWO MOS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRANIOPLASTIC KIT METHYL METHACRYLATE FOR CRANIOPLASTY GXP CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death