BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDYS-ALIF

    MDR report key: 16989321 · Received May 23, 2023

    Report

    Report Number
    3009962553-2023-00001
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 19, 2023
    Manufacturer
    CLARIANCE SAS
    Product Code
    OVD
    UDI-DI
    03700780626953
    PMA / PMN Number
    K172083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN EXPIRED IDYS-ALIF CAGE WAS IMPLANTED INTO THE PATIENT. THIS PRODUCT HAD EXPIRED ON 01/15/2023. CLARIANCE NOTIFIED APEX MEDICAL REGARDING THE EXPIRATION OF THE DEVICE AND REQUESTED IT BE RETURNED ON 02/02/2023. A REPRESENTATIVE OF APEX MEDICAL RESPONDED ON THAT THIS SPECIFIC PRODUCT (AND LOT NUMBER) 03/01/2023 THAT THIS PRODUCT WAS NOT IN THE POSESSION OF APEX MEDICAL. THE CAGE WAS SUBSEQUENTLY IMPLANTED DURING SURGERY ON (B)(6) 2023.

    Description of Event or Problem · 0

    ON (B)(6) 2023 AN EXPIRED CAGE WAS IMPLANTED INTO A PATIENT DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218148 IDYS-ALIF IDYS-ALIF CAGE 26X32 - H16MM - 14 OVD CLARIANCE SAS 24520614-S H465X-HC02Y 03700780626953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown