BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVUX CERVICAL CAGE-X

    MDR report key: 12440270 · Received September 8, 2021

    Report

    Report Number
    3009394448-2021-00001
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    August 10, 2021
    Report Date
    September 7, 2021
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS EVENT DID NOT RESULT IN A DEATH OR LIFE-THREATENING INJURY. THERE WAS NO DEVICE MALFUNCTION REPORTED WITH THE DEVICES. INDEX PROCEDURE WAS A 4 LEVEL CERVICAL FUSION, COMPLETED ON (B)(6) 2021. PATIENT HAD RADICULAR SYMPTOMS AND AXIAL NECK PAIN DUE TO POSTERIOR FACET DEGENERATION. POST INDEX PROCEDURE, PATIENT REPORTED DELTOID WEAKNESS, BUT NO PAIN. FOLLOW UP CT IMAGING REVEALED 2 IMPLANTS WERE MALPOSITIONED MEDIALLY. THERE WAS NO MALFUNCTION OF THE DEVICE. REVISION PROCEDURE TO REMOVE MALPOSITIONED CAGE WAS COMPLETED AS PLANNED, BOTH SUSPECT IMPLANTS WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339145 CAVUX CERVICAL CAGE-X INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-203 052690

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention