BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM ACDF IMPLANT KIT - 18X12MM ANGLED

    MDR report key: 18007896 · Received October 25, 2023

    Report

    Report Number
    3027305073-2023-00001
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    October 5, 2023
    Report Date
    October 19, 2023
    Manufacturer
    PRESSIO, INC.
    Product Code
    PHQ
    UDI-DI
    00850039803024
    PMA / PMN Number
    K200301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD A C3-C4 ANTERIOR FUSION PROCEDURE THAT INCLUDED THE USE OF AN 18MM ANGLED CONTINUUM IMPLANT WITH AN 8MM INTERBODY CAGE FILLED WITH AUTOGRAFT. TWO WEEKS POST OP IT WAS IDENTIFIED THAT THE INTERBODY CAGE AND CONTINUUM IMPLANT HAD MIGRATED FORWARD RESULTING IN THE NEED FOR A REOPERATION. ON THE X-RAY IMAGING, THE SURGEON OBSERVED THAT THE CONTINUUM IMPLANT WAS NOT FLUSH AGAINST THE INTERBODY CAGE WHICH COULD HAVE ALLOWED THE MIGRATION OF THE INTERBODY CAGE. THE PATIENT HAD A TERRIBLE COUGH DUE TO COVID POST OPERATIVELY WHICH COULD HAVE CONTRIBUTED TO THE MIGRATION OF THE INTERBODY CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140723 CONTINUUM ACDF IMPLANT KIT - 18X12MM ANGLED ACDF IMPLANT SYSTEM PHQ PRESSIO, INC. PS-01-1812A 5008638 00850039803024

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention DEPUY PROTI 360 8MM 15 DEGREES PEEK INTERBODY CAGE.