BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 10812257 · Received November 9, 2020

    Report

    Report Number
    3009351194-2020-00016
    Event Type
    Injury
    Date Received
    November 9, 2020
    Date of Event
    October 13, 2020
    Report Date
    October 13, 2020
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES, HOWEVER, A LIKE DEVICE CATALOG # CAR-08, 510K # K181348 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE TOE. IT WAS REPORTED THAT THE PATIENT IS IN PAIN WHICH LEAD TO A REVISION AND REMOVAL OF THE IMPLANT. DURING THE REVISION A FUSION WAS PERFORMED USING AN ALLOGRAFT BONE GRAFT TO FILL THE VOIDE IN COMBINATION WIT A PLATE AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278231 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC CAR-08-AUS F022119001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention