BEUDAMED
    FDA Adverse Event Death Summary report: N

    LATERAL F3D 18 MM IMPLANT; COBB ELEVATOR

    MDR report key: 21877722 · Received April 21, 2025

    Report

    Report Number
    3008583793-2025-00002
    Event Type
    Death
    Date Received
    April 21, 2025
    Date of Event
    March 11, 2025
    Report Date
    April 9, 2025
    Manufacturer
    ZAVATION MEDICAL PRODUCTS, LLC
    Product Code
    KWQ
    UDI-DI
    M7253LLIS5508100
    PMA / PMN Number
    K231743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PRODUCT MANAGER WAS PRESENT IN THE OPERATING ROOM FOR A CASE INVOLVING A LATERAL L1-L5 LUMBAR INTERBODY FUSION (LLIF) PROCEDURE. THE PATIENT WAS POSITIONED LATERALLY WITH THE LEFT SIDE FACING UP. THE SURGEON MADE A SMALL INCISION ON THE LATERAL FLANK FOR ACCESS TO THE L1 VERTEBRAL BODY. THE PROCEDURE COMMENCED WITH THE PLACEMENT OF A ZAVATION LATERAL RETRACTOR SYSTEM, THE DISK WAS DISSECTIONED, AND THEN THE LATERAL F3D IMPLANT WAS PLACED INTO AT THE L1 LEVEL. THE OPERATION PROGRESSED TO L2, WHERE THE SURGEON UTILIZED A COBB SPINAL ELEVATOR TO EXCISE OSTEOPHYTES FOR ADEQUATE ACCESS TO THE L2 VERTEBRA. DURING THE PROCEDURE, THE PATIENT BEGAN TO EXPERIENCE SIGNIFICANT HEMORRHAGING. A GENERAL SURGEON WAS URGENTLY CALLED TO THE OPERATING ROOM FOR LIFE-SAVING INTERVENTION. UNFORTUNATELY, THE SOURCE OF THE BLEEDING COULD NOT BE IDENTIFIED IN TIME, AND THE PATIENT ULTIMATELY SUCCUMBED TO THE HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911532 LATERAL F3D 18 MM IMPLANT; COBB ELEVATOR LATERAL CAGE; COBB ELEVATOR KWQ ZAVATION MEDICAL PRODUCTS, LLC 3LL1855-0810; 7802-180 SM154579; SM152950 M7253LLIS5508100

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Death