BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPF IMPLANTABLE BONE GROWTH STIMULATOR

    MDR report key: 960610 · Received December 6, 2007

    Report

    Report Number
    2242816-2007-00065
    Event Type
    Death
    Date Received
    December 6, 2007
    Date of Event
    November 5, 2007
    Report Date
    November 19, 2007
    Manufacturer
    EBI
    Product Code
    LOE
    PMA / PMN Number
    P850035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DHR SHOWS THAT THE REQUIRED MANUFACTURING, INSPECTION AND TESTING PROCESSES WERE COMPLETED IN ACCORDANCE WITH ESTABLISHED PROCEDURES. STERILIZATION AND STERILITY REQUIREMENTS WERE ALSO IN COMPLIANCE WITH ESTABLISHED PROCEDURES AND APPLICABLE INDUSTRY STANDARDS.

    Description of Event or Problem · 1

    PATIENT UNDERWENT SPINAL SURGERY IN 2007: LAMINOTOMY, DECOMPRESSION WITH SOME OPEN REDUCTION OF FRACTURE WITH KYPHOPLASTY, EXPLORATION OF FUSION WITH REMOVAL AND REPLACEMENT OF HARDWARE, PLACEMENT OF EXTENDED INSTRUMENTATION WITH POSTERIOR FUSION, AND SUPPLEMENTATION OF FUSION WITH AUTOGRAFT, ALLOGRAFT, BMP AND PLACEMENT OF SPF BONE STIMULATOR. THE PT RETURNED TO THE HOSP WITH AN INFECTION. IT WAS REPORTED THAT SURGICAL EXPLORATION TWO MONTHS LATER, FOUND PUS SURROUNDING THE SPF UNIT. THE TISSUE SURROUNDING THE WIRES AND BONE SCREWS WAS ALSO INFECTED. PATIENT DIED SEVERAL DAYS AFTER SURGERY FROM COMPLICATIONS OF INFECTION. SURGEON STATED THAT THE INFECTION WENT UNTREATED FOR SEVERAL WEEKS. THE HARDWARE (OTHER THAN THE SPF UNIT), ALLOGRAFT AND BMP WERE NOT BIOMED/EBI DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPF IMPLANTABLE BONE GROWTH STIMULATOR LOE EBI XL IIB 2/DM

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| R