BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 1 3 MM

    MDR report key: 8041893 · Received November 6, 2018

    Report

    Report Number
    0002023141-2018-00884
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 4, 2018
    Report Date
    March 13, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SPLINE IMPLANT WAS RETURNED FOR INSPECTION WITH A TRANSFER MOUNT. THE IMPLANT SHOWS SIGNS OF WEAR FROM USE. THE PRODUCT WAS FUNCTIONALLY TESTED, AND IT WAS CONFIRMED THAT THE MOUNT COULD NOT BE REMOVED WITHOUT EXCESSIVE REMOVAL TORQUE. THE EVENT WAS CONFIRMED THROUGH THIS MALFUNCTION. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: UDI: (B)(4). DEVICE EVALUATED BY MANUFACTURER: CHANGE "NO" TO "YES."

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). ADDITIONAL 510K NUMBER: K943604.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOUNT COULD NOT BE REMOVED FROM THE IMPLANT (1990). ANOTHER IMPLANT WAS PLACED. TOOTH LOCATION 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882022 IMPL TWIST MP-1 3.75 MM 1 3 MM DENTAL IMPLANT DZE ZIMMER DENTAL 63459449

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR