BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 1 0 MM

    MDR report key: 17907473 · Received October 10, 2023

    Report

    Report Number
    0002023141-2023-02828
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 5, 2023
    Report Date
    March 19, 2024
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. ZIMVIE RECEIVED ONE IMPLANT FOR EVALUATION. VISUAL EVALUATION / FUNCTIONAL TEST WAS PERFORMED, IMPLANT SHOWS SLIGHT WEAR HOWEVER MOUNT WAS ABLE TO DISENGAGE FROM IMPLANT AS INTENDED. NO MALFUNCTION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS TORQUE OR SPEED APPLIED DURING PLACEMENT/SEATING EXCEEDS RECOMMENDED VALUE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID NOT OCCUR. THE MOUNT WAS ABLE TO DISENGAGE FROM IMPLANT AS INTENDED. THE REPORTED IS UNCONFIRMED HOWEVER THE COOB COULD NOT BE VERIFIED SINCE THE CONDITION OF THE PRODUCT/PACKAGING WHEN RECEIVED BY THE CUSTOMER WAS UNKNOWN. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). E1: INITIAL REPORTER¿S TITLE IS NOT PROVIDED / UNKNOWN. G4: ADDITIONAL 510(K) NUMBER IS K943604.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MOUNT COULD NOT BE REMOVED. TOOTH NUMBER 7. THE REPLACEMENT PART WAS INSERTED, AND THE MOUNT WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291425 IMPL TWIST MP-1 3.75 MM 1 0 MM DENTAL IMPLANT DZE ZIMMER DENTAL 2022070043 00889024013124

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female