BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLXFIT®15 POSTERIOR LUMBAR SYSTEM

    MDR report key: 21877723 · Received April 21, 2025

    Report

    Report Number
    3008583793-0250-00003
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 10, 2025
    Manufacturer
    ZAVATION MEDICAL PRODUCTS, LLC
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    L2-L3 POSTERIOR LUMBAR SURGERY- DISC SPACE VERY TIGHT AT L2/L3 - DIFFICULTY INSERTING THE SHORTEST CAGE - 8MM CAGE. SURGEON CONTINUED TO CAGE DESPITE DIFFICULTY WITH INSERTION. SURGEON TOOK MEDIAL INSERTION ANGLE. SURGEON PROCEEDED TO MALLET ON INSERTER TO POSITION THE CAGE MORE ANTERIOR PRIOR TO ARTICULATING THE CAGE, PATIENT HAD ANTERIOR OSTEOPHYTES AND SCLEROTIC BONE THAT MAY HAVE PREVENTED THE CAGE FROM ADVANCING. THE FLXFIT CAGE WAS IN THE DISC SPACE AND CAGE DISARTICULATED IN-SITU. DISTAL END OF CAGE WITH WEDGES LEFT IN DISC SPACE. THE L2-L3 LEVEL WAS LOCKED DOWN WITH PEDICLE SCREWS TO PREVENT THE CAGE COMPONENTS FROM BACKING OUT. THERE WAS A SIGNIFICANT DURAL TEAR, HOWEVER, UNSURE WHEN TEAR HAPPENED. PATIENT HAS LOST SENSATION AND ABILITY TO MOVE RIGHT LEG BELOW HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911533 FLXFIT®15 POSTERIOR LUMBAR SYSTEM CAGE MAX ZAVATION MEDICAL PRODUCTS, LLC AT4008 SM152470-L

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other