BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 8 MM

    MDR report key: 14789133 · Received June 23, 2022

    Report

    Report Number
    0002023141-2022-01600
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    May 30, 2022
    Report Date
    December 9, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024013162
    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). 510(K) NUMBER IS K962106.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. THE REPORTED DEVICE WAS RETURNED, AND THE REPORTED EVENT WAS UNCONFIRMED. THE ALLEGED COOB COULD NOT BE VERIFIED. BASED ON THE EVALUATION, THE DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED PRODUCT THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE TRENDS OR ACTIONABLE TRENDS FOR THE REPORTED EVENT OR DEVICE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. 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, WERE 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 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. DURING A FUNCTIONAL TEST THE IMPLANT EASILY DISENGAGED FROM THE FIXTURE MOUNT. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE PROBABLE CAUSES ARE NOT APPLICABLE TO THE REPORTED EVENT SINCE THE DEVICE MALFUNCTION DID NOT OCCUR AND THE EVENT IS UNCONFIRMED THROUGH VISUAL AND PHYSICAL INSPECTION. 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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMVIE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    DOCTOR INDICATED MALFUNCTION. THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH SITE # 14 (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
    811454 IMPL TWIST MP-1 5.0 MM 8 MM DENTAL IMPLANT DZE ZIMMER DENTAL 1993 2021090146 00889024013162

    Patients

    Seq Age Sex Outcome Treatment
    1 Male