BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVUX CERVICAL CAGE-X

    MDR report key: 14780792 · Received June 22, 2022

    Report

    Report Number
    3009394448-2022-00002
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    June 2, 2022
    Report Date
    June 22, 2022
    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
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE WAS NO DEVICE MALFUNCTION. THE INDEX PROCEDURE WAS A ONE LEVEL CERVICAL FUSION AT C4-C5 COMPLETED ON (B)(6) 2022. INDEX PROCEDURE OUTCOME WAS AS EXPECTED, NO ABNORMALITIES NOTED. POST-INDEX PROCEDURE, PATIENT REPORTED PAIN, CT IMAGING REVEALED ONE IMPLANT MALPOSITIONED MEDIALLY. REVISION PROCEDURE ON (B)(6) 2022 WAS A SUCCESSFUL FORAMINOTOMY AND CAGE WAS REMOVED. NO NEGATIVE CLINICAL SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256618 CAVUX CERVICAL CAGE-X CERVICAL CAGE ODP PROVIDENCE MEDICAL TECHNOLOGY, INC PD-31-203 CX092202

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention