BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA DEVICE 10MM T20-0329

    MDR report key: 11720462 · Received April 23, 2021

    Report

    Report Number
    3009351194-2021-00112
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    April 1, 2021
    Report Date
    July 22, 2021
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THERE ARE MANY CLINICAL FACTORS THAT CAN AFFECT THE RESULTS OF ANY SURGERY, SUCH AS SURGICAL TECHNIQUE, PRE-OPERATIVE AND POST-OPERATIVE CARE, THE IMPLANT, PATIENT PATHOLOGY AND DAILY ACTIVITY. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE BIG TOE. THE PATIENT WAS IN CONSISTENT PAIN, SO THE SURGEON REMOVED THE CARTIVA IMPLANT AND FILLED WITH ALLOVANCE HYBRID BONE VOID FILLER AND REVISED TO FUSION USING MEDARTIS MTP PLATE.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. PMA/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # CAR-10, PMA # P150017 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE BIG TOE. THE PATIENT WAS IN CONSISTENT PAIN, SO THE SURGEON REMOVED THE CARTIVA IMPLANT AND FILLED WITH ALLOVANCE HYBRID BONE VOID FILLER AND REVISED TO FUSION USING MEDARTIS MTP PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615398 CARTIVA DEVICE 10MM T20-0329 PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention