BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVUX CERVICAL CAGE-B

    MDR report key: 8049334 · Received November 7, 2018

    Report

    Report Number
    3009394448-2018-00001
    Event Type
    Injury
    Date Received
    November 7, 2018
    Report Date
    October 23, 2018
    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 · 1

    A PATIENT WAS TREATED AT C4- C5 LEVEL IN A CASE THAT INVOLVED PROVIDENCE PRODUCTS. THE PATIENT LATER EXPERIENCED A C5 PALSY. THE SURGERY WAS REVISED, PATIENT HAS RESIDUAL DELTOID WEAKNESS. NO PRODUCT MALFUNCTIONS WERE REPORTED. THE PHYSICIAN NOTED THAT THE CAGES MAY HAVE BEEN MALPOSITIONED AND CAUSED THE SUSPECTED ISSUE. THE PHYSICIAN DECLINED TO PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888221 CAVUX CERVICAL CAGE-B CERVICAL CAGE ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-200 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention