BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH

    MDR report key: 15207987 · Received August 11, 2022

    Report

    Report Number
    0002023141-2022-02016
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    July 22, 2022
    Report Date
    January 18, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024343597
    PMA / PMN Number
    K142082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE (1) EMPTY PACKAGING / OUTER VIAL FOR A EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH (CM3111) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PACKAGING IDENTIFIED THE OUTER VIAL ALREADY OPEN / EMPTY. NO PRODUCT RETURNED. THE COOB IS NON-VERIFIABLE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE CUSTOMER DID PROVIDE THREE (3) PICTURES. FURTHER REVIEW OF THE CUSTOMER'S PICTURES IDENTIFIED THE OUTER VIAL WITH THE TAMPER SEAL ALREADY BROKEN. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1221695). 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 (1221695) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: INCORRECT COMPONENT QUANTITY. THEREFORE, BASED ON THE AVAILABLE INFORMATION, PACKAGING MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. AS THE PACKAGING WAS ALREADY OPENED, THE CIRCUMSTANCES OF THE DEVICE DELIVERY COULD NOT BE RECREATED. THE ALLEGED COOB COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN GOING TO PLACE AN IMPLANT, SHE NOTICED THAT THE THIRD BOX, THE IMPLANT AND COVER SCREW WERE MISSING. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383089 EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH DENTAL IMPLANT DZE ZIMMER DENTAL CM3111 1221695 00889024343597

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male