BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZAVATION EZSPAND SYSTEM

    MDR report key: 21877724 · Received April 21, 2025

    Report

    Report Number
    3008583793-2025-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    January 30, 2025
    Report Date
    February 26, 2025
    Manufacturer
    ZAVATION MEDICAL PRODUCTS, LLC
    Product Code
    MAX
    UDI-DI
    00842166126480
    PMA / PMN Number
    K191339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ORIGINAL SURGERY WAS (B)(6) 2025. SURGEON REVIEWED 3 MONTHS POST OP IMAGES AND NOTICED THAT THE CAGE IS HAS BACKED OUT OF THE DISC SPACE 1CM APPROXIMATELY. CAGE DOES NOT LOOK COLLAPSED IN IMAGE. PATIENT HAD SUBSEQUENT RADICULAR LEG PAIN DUE TO CAGE POSITION. THE PATIENT REQUIRED EXPLANT SURGERY TO REMOVE CAGE. SURGERY TOOK PLACE ON (B)(6) 2025. SURGEON IS MONITORING 2 OTHER PATIENTS WHERE CAGES LOOK TO BE POSTERIOR BACKING OUT OF DISK SPACE BUT NOT COLLAPSED. BOTH PATIENTS ARE ASSYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518777 ZAVATION EZSPAND SYSTEM PLIF / TPLIF 9 X 27 X 0DEGREES MAX ZAVATION MEDICAL PRODUCTS, LLC 360-H02700 00842166126480

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention