BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 1 0 MM

    MDR report key: 16870154 · Received May 4, 2023

    Report

    Report Number
    0002023141-2023-01242
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Date of Event
    March 22, 2023
    Report Date
    September 24, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE IMPLANT FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED SIGNS OF USE, BONE / TISSUE ATTACHED TO EXTERNAL THREADS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT VERIFIED THE IMPLANT CANNOT BE DISENGAGED FROM THE MOUNT. 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. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION. ZIMVIE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT, THE IMPLANT WAS REMOVED, AND ANOTHER IMPLANT WAS PLACED. TOOTH SITE #13 (UNIVERSAL).

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434352 IMPL TWIST MP-1 3.75 MM 1 0 MM DENTAL IMPLANT DZE ZIMMER DENTAL 2021060161

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Prefer Not To Disclose