BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC-PLUS SOLUTION

    MDR report key: 940944 · Received November 8, 2007

    Report

    Report Number
    9612771-2007-00053
    Event Type
    Injury
    Date Received
    November 8, 2007
    Date of Event
    May 1, 2002
    Manufacturer
    PLUS ORTHOPEDICS AG
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "RETROSPECTIVE ONE-TIME SUMMARY REPORT." THIS REPORT COVERS A TOTAL OF 3 SERIOUS INJURY MDR'S. ATTACHED IS A SPREADSHEET SUMMARIZING INDIVIDUAL EVENT DATA FOR 2 REPORTS ADDITIONAL TO THE ONE SUMMARIZED ON THIS FDA 3500A FORM. THE REASON THE FOREIGN-SOURCE MDR REPORTABLE EVENTS (BEING SUBMITTED UNDER EXEMPTION) ARE BEING FILED LATE IS DUE TO A MISUNDERSTANDING BY THE MANUFACTURER, PLUS ORTHOPEDICS AG, OF THE MDR REQUIREMENTS APPLICABLE TO FOREIGN MANUFACTURERS. AT THE TIME OF THESE EVENTS PLUS ORTHOPEDICS AG ERRONEOUSLY BELIEVED THAT FOREIGN EVENTS WERE REPORTABLE ONLY IF THE EVENT INVOLVED A DEVICE FROM THE "SAME LOT" AS DEVICES THAT WERE DISTRIBUTED IN THE UNITED STATES. THIS THE MDR'S THAT ARE THE SUBJECT OF THIS RETROSPECTIVE ONE-TIME SUMMARY REPORT WERE NOT APPROPRIATELY EVALUATED FOR MDR REPORTABILITY, AND NOT REPORTED TO FDA. APPROPRIATE CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    A KOREAN DISTRIBUTOR HAS INDICATED THAT DISLOCATIONS HAVE OCCURRED AND REVISION CASES WERE DONE. REQUESTS FROM PLUS ORTHOPEDICS AG FOR DETAILS OF REPORTED CONDITION, X-RAYS AND EXPLANTS WERE UNSUCCESSFUL IN OBTAINING ADDITIONAL INFORMATION, AND NO COMPLAINTS HAVE BEEN SUBMITTED. LIMITED INFORMATION AVAILABLE IS INSUFFICIENT TO ARRIVE AT ANY CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TC-PLUS SOLUTION JWH PLUS ORTHOPEDICS AG 21609 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention