BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVUX CERVICAL CAGE-X

    MDR report key: 20689055 · Received November 14, 2024

    Report

    Report Number
    3009394448-2024-00005
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 14, 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, AND REMOVAL WAS NOT DUE TO THE FAILURE OF THE DEVICE. THE INDEX PROCEDURE WAS A SINGLE CAGE PLACED AT C1-C2 ON THE LEFT SIDE INITIALLY USING PD-31-203 CERVICAL CAGE-X, 4MM. THE REVISION PROCEDURE OCCURRED ON (B)(6) 2024 AND WAS DUE TO A CSF LEAK THAT WAS NOT RELATED TO PROVIDENCE MEDICAL TECHNOLOGY PRODUCTS. DURING THE REVISION THE LATERAL MASS SCREWS (NOT PROVIDENCE MEDICAL TECHNOLOGY PRODUCTS) WERE REVISED AS WELL, AND THEN THE CAGE-X WAS REPLACED WITH PD-31-204 CERVICAL CAGE-X, 5MM. THE REVISION CASE WAS PERFORMED SUCCESSFULLY. THE PATIENT IS RECOVERING WELL/AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169084 CAVUX CERVICAL CAGE-X Intervertebral fusion device with bone graft, cervical ODP PROVIDENCE MEDICAL TECHNOLOGY, INC PD-31-203

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention