BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 12M M OCTAGON

    MDR report key: 8091791 · Received November 20, 2018

    Report

    Report Number
    0002023141-2018-00918
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 27, 2017
    Report Date
    March 25, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ZIMMER SWISSPLUS OCTAGON IMPLANT WAS RETURNED FOR INSPECTION ATTACHED TO AN ABUTMENT. VISUAL INSPECTION REVEALED THAT THE DEVICE WAS FRACTURED AT THE COLLAR. THE OTHER PORTION OF THE IMPLANT WAS NOT RETURNED FOR INSPECTION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO UNAUTHORIZED DEVIATIONS OR NON-CONFORMANCES WHICH COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT WERE DOCUMENTED AS PART OF THE DHR. LOT WAS INSPECTED AND ACCEPTED BY QA. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. ALSO A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. A SINGULAR ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510K NUMBERS: K011245 AND K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT ((B)(4)) FRACTURED INSIDE OF THE PATIENT'S MOUTH. PART OF THE IMPLANT IS STILL STUCK IN THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931693 IMPL TAPERED SP 3.7MM 12M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL 62870853

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR