BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 10304548 · Received July 21, 2020

    Report

    Report Number
    3009351194-2020-00005
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 25, 2020
    Report Date
    June 29, 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-10-US, P150017 WAS CLEARED IN THE UNITED STATES. THE PRODUCT WAS NOT RETURNED NOR WERE IMAGES PROVIDED FOR REVIEW; THEREFORE, PRODUCT ANALYSIS CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOE SURGERY. THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN. UPON REMOVAL THE IMPLANT WAS IN GOOD POSITION HOWEVER IT WAS WORN AND INDENTED. THE PATIENT HAD THE TOE FUSED WITH A PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764330 CARTIVA PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC CAR-10-AUS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention