BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 1 0 MM

    MDR report key: 10524907 · Received September 11, 2020

    Report

    Report Number
    0002023141-2020-01418
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 1, 2020
    Report Date
    January 4, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024013124
    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 IMPL TWIST MP-1 3.75 MM 1 0 MM (1989) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED MINIMAL SIGNS OF WEAR ABOUT THE IMPLANT THREADS, MOUNT, AND TINES. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 15 (UNIVERSAL) AND WAS REMOVED THE SAME DAY. THE REPORTED EVENT COULD NOT BE RECREATED WHEN THE RETURNED PRODUCT WAS FUNCTIONALLY TESTED. THE MOUNT WAS ABLE TO DISENGAGE WITH LITTLE EFFORT USING NORMAL HAND TOOLS. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2019060326. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2019060326) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (STUCK COMPONENTS) OR PRODUCT (1989). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS UNCONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G7: CHECKED "FOLLOW-UP."

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT WEIGHT: NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER: K943604. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT PLACEMENT THE IMPLANT FIXTURE MOUNT WAS UNABLE TO DISENGAGE FROM THE IMPLANT (1989). IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED INSTEAD. TOOTH LOCATION 15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989493 IMPL TWIST MP-1 3.75 MM 1 0 MM DENTAL IMPLANT DZE ZIMMER DENTAL 1989 2019060326 00889024013124

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR