BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZSPAND CAGE

    MDR report key: 22879199 · Received August 22, 2025

    Report

    Report Number
    3008583793-2025-00004
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 22, 2025
    Manufacturer
    ZAVATION MEDICAL PRODUCTS, LLC
    Product Code
    MAX
    UDI-DI
    00842166146303
    PMA / PMN Number
    K191339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CAGE APPEARS TO BE COLLAPSING ON POST OPERATIVE X-RAYS, FOOT DROP PRESENTED AT 2 WEEKS POST OP. FURTHER DECOMMESSION PERFORMED AND FIXED ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2667780 EZSPAND CAGE PLIF/T-PLIF EXPANDIBLE CAGE 9X23X10°, 8.5-13MM MAX ZAVATION MEDICAL PRODUCTS, LLC 00842166146303

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other