BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL SIMPLEX P

    MDR report key: 249744 · Received November 10, 1999

    Report

    Report Number
    249744
    Event Type
    Death
    Date Received
    November 10, 1999
    Date of Event
    October 25, 1999
    Report Date
    November 10, 1999
    Manufacturer
    HOWMEDICA, INC., PFIZER HOSP PRODUCTS GROUP
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADMITTING DIAGNOSIS: SEVERE OSTEOPOROSIS WITH COMPRESSION FRACTURE OF T-12 AND WEDGING OF THE THORACOLUMBAR AREA WITH MULTIPLE SMALL FRACTURES. DISCHARGE DIAGNOSIS: SAME. OPERATION PERFORMED: PERCUTANEOUS VERTEBROPLASTY T8 THROUGH L3. AT THE END OF SURGICAL PROCEDURE (PERCUTANEOUS VERTEBROPLASTY OF THORACIC AND LUMBAR AREAS) PT CODED AND DEATH OCCURRED. EXPIRATION DATE OF POWDERED COMPONENT 1/2002; LIQUID COMPONENT 2/2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SIMPLEX P Implant RADIOPAQUE BONE CEMENT LOD HOWMEDICA, INC., PFIZER HOSP PRODUCTS GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death SURGICAL SIMPLEX P (FROM 10/25/1999).