BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTIVA SCI IMPLANT FOR MTP

    MDR report key: 13606248 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00039
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    May 16, 2019
    Report Date
    May 16, 2019
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS REGARDING MEDICAL DEVICE REPORTING AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY OR MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTION OR IS RELATED TO A DEATH OR INJURY. 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.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

    FEEDBACK RECEIVED AS PART OF (B)(4) PATIENT SURVEY PATIENT REPORTED CONTINUED PAIN SUBSIDENCE AND LOSS OF MOTION ON BOTH TOES POSTOPERATIVELY ((B)(6) 2017 AND (B)(6) 2018) RESULTING IN NEED FOR CONVERSION TO FUSION IN BOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2435800 CARTIVA SCI IMPLANT FOR MTP METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PROSTHESIS, PNW CARTIVA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention