BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST BNE GFT ACCELERATE T50206 GRAFTON DBF 6CC

    MDR report key: 16428498 · Received February 23, 2023

    Report

    Report Number
    16428498
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    October 17, 2022
    Report Date
    January 19, 2023
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INC.
    Product Code
    MBP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    POSSIBLE CONTAMINATION OF ALLOGRAFT OR ALLOGRAFT BONE KIT WITH ASPERGILLUS FUMIGATUS. PATIENT RECEIVED ALLOGRAFT ON (B)(6) 2022. RETURNED TO THE OPERATING ROOM ON (B)(6) 2022 FOR EXPLORATION OF WOUND AND WOUND VAC PLACEMENT, ASPERGILLUS FOUND ON WOUND CULTURE. PATIENT AGAIN RETURNED TO OPERATING ROOM ON (B)(6) 2022 FOR WOUND CLEANOUT, BONE GRAFT FROM PATIENTS R ILIAC CREST. OPERATING ROOM, VENTILATION DUCTS AND CONNECTED OPERATING ROOM SUITES UNDERWENT AIR TESTING ONCE ASPERGILLUS WAS FOUND AND TESTING WAS NEGATIVE. OPERATING ROOM AND CONNECTING SUITES TESTED AGAIN AFTER AND AGAIN TESTING NEGATIVE. ALSO CHECKING WITH LOCAL FACILITIES FOR POSSIBLE ASPERGILLUS INFECTIONS AS ANOTHER PATIENT IN THE FACILITY WITH SIMILAR SURGERY HAS ASPERGILLUS INFECTION DURING THE MONTH OF OCTOBER. SURGERY WAS NOT ON SAME DAY BUT IN SAME MONTH WITH THE SAME ALLOGRAFT DEVICES USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473929 ST BNE GFT ACCELERATE T50206 GRAFTON DBF 6CC ST BNE GFT ACCELERATE T50206 GRAFTON DBF 6CC MBP MEDTRONIC SOFAMOR DANEK INC. A48174-101

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female