BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 13606408 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00028
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    October 23, 2018
    Report Date
    January 8, 2021
    Manufacturer
    CARTIVA
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED NOR WERE IMAGES PROVIDED FOR REVIEW; THEREFORE, PRODUCT ANALYSIS CANNOT BE PERFORMED. ON (B)(6) 2020 STRYKER TRAUMA AND EXTREMITIES ACQUIRED CARTIVA, WRIGHT MEDICAL, TORNIER INC. AND TORNIER SAS. AN EFFORT WAS MADE TO ALIGN THE ACQUIRED ENTITY COMPLAINT FILES WITH STRYKER'S POLICIES AND PROCEDURES. STRYKER HAS PERFORMED RETROSPECTIVE REVIEW OF COMPLAINTS AND THE REPORTABILITY DECISION WAS REVISED TO REPORT THIS INCIDENT UNDER THE MDR/VIGILANCE PROCESS.

    Description of Event or Problem · 0

    "CUSTOMER FEEDBACK RECEIVED VIA EMAIL INFO (B)(6) ALLEGING A "FAILED IMPLANT. DOCTOR OFFERED FUSION FOR FUTURE TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390533 CARTIVA PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other