BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTURA MEDICAL

    MDR report key: 23084769 · Received September 18, 2025

    Report

    Report Number
    3015941638-2025-00008
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    July 31, 2025
    Report Date
    September 2, 2025
    Manufacturer
    ASTURA MEDICAL
    Product Code
    MAX
    UDI-DI
    00841379180876
    PMA / PMN Number
    K182877
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ITEM WAS RETURNED FROM HOSPITAL AND TESTED AND WORKED AS IT SHOULD. ORIGINAL RECEIVING INSPECTION REPORTS SHOW IMPLANT TO BE IN SPECIFICATION.

    Description of Event or Problem · 0

    EXPANDABLE SPACER BEGAN TO MIGRATE OUT OF THE DISC SPACE, REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831815 ASTURA MEDICAL METALLIC SPINAL INTERBODY FUSION CAGE MAX ASTURA MEDICAL BH092409D 793505I 00841379180876

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention