BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVUX CERVICAL CAGE

    MDR report key: 19697636 · Received July 8, 2024

    Report

    Report Number
    3009394448-2024-00001
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 8, 2024
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY, INC
    Product Code
    ODP
    PMA / PMN Number
    K122801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THERE WAS NO DEVICE MALFUNCTION, REVISION PROCEDURE WAS DUE TO POST-OP PAIN. THE INDEX PROCEDURE WAS A TWO-LEVEL CASE AT C4-C6 ON (B)(6)2024. POST INDEX PROCEDURE, PATIENT WAS REFERRED DUE TO PAIN AND WEAKNESS. REVISION PROCEDURE TO REMOVE CAGE ON BOTH SIDES AT C5-C6 TOOK PLACE ON (B)(6) 2024. THE CASE WAS COMPLETED SUCCESSFULLY, AND PATIENT IS RECOVERING AS EXPECTED, WITH NO CLINICAL SEQUELAE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257941 CAVUX CERVICAL CAGE Intervertebral fusion device with bone graft, cervical ODP PROVIDENCE MEDICAL TECHNOLOGY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention