BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 11664443 · Received April 14, 2021

    Report

    Report Number
    3009351194-2021-00098
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    October 6, 2020
    Report Date
    March 17, 2021
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED ON A POST ON SOCIAL MEDIA THAT THE PATIENT HAD TWO IMPLANTS THAT FAILED. PATIENT UNDERWENT A REVISION SURGERY WITH A FUSION AND REPORTED THAT BIG TOE IS NOW HALF AN INCH SHORTER. THE PATIENT REPORTS FALLING FREQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561364 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention