BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVUX CERVICAL CAGE

    MDR report key: 20055709 · Received August 23, 2024

    Report

    Report Number
    3009394448-2024-00003
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 31, 2024
    Report Date
    August 23, 2024
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY, INC
    Product Code
    ODP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON 07/31/2024 PMT WAS NOTIFIED THAT A REVISION SURGERY WAS INTENDED TO TAKE PLACE FOR CAGE REMOVAL. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION, IT WAS STATED THAT THE IMPLANT MAY BE CONTRIBUTING TO SOME RADICULAR SYMPTOMS IN THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, OFFER EXPLANTATION SUPPORT, AND SEEK PATIENT UPDATES, BUT PMT HAS NOT RECEIVED ANY ADDITIONAL INFORMATION. AS SUCH, PROVIDENCE IS FILING THIS INITIAL REPORT AND WILL SUPPLEMENT IT AS ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743521 CAVUX CERVICAL CAGE Intervertebral fusion device with bone graft, cervical ODP PROVIDENCE MEDICAL TECHNOLOGY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention