BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 1 3 MM

    MDR report key: 9623505 · Received January 23, 2020

    Report

    Report Number
    0002023141-2020-00155
    Event Type
    Malfunction
    Date Received
    January 23, 2020
    Date of Event
    December 10, 2019
    Report Date
    March 30, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPLANT WAS RETURNED FOR INVESTIGATION WITH ITS BUNDLED MOUNT. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE AND NO APPARENT MALFUNCTION. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT AND IT WAS DETERMINED THE DEVICE PASSED FUNCTIONAL TESTING WHEN THE MOUNT PROPERLY ASSEMBLED AND SEPARATED FROM THE IMPLANT AS THE MOUNT SCREW PROPERLY THREADED THROUGH THE INTERNAL IMPLANT THREADS. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED. A DEVICE MALFUNCTION FOR THE IMPLANT WAS NOT FOUND. A ROOT CAUSE CANNOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: CHANGED "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). PATIENT WEIGHT NOT PROVIDED/UNKNOWN. ACCOUNT ADDRESS NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBER: K943604. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BECAME STUCK TO THE GINGIVAL CUFF. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE. TOOTH LOCATION 22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85397 IMPL TWIST MP-1 3.75 MM 1 3 MM DENTAL IMPANT DZE ZIMMER DENTAL 63724509

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR