BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11705502 · Received April 22, 2021

    Report

    Report Number
    0002023141-2021-01008
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    January 27, 2021
    Report Date
    August 24, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024343887
    PMA / PMN Number
    K142082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4) AN EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH (CT3111) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS AND DEBRIS DUE TO USAGE. FRACTURE AT THE COLLAR. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1233123). 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 (1233123) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT IMPLANT AT TOOTH LOCATION #42 WAS UNABLE TO PLACE DUE TO THE FRACTURE OF THE HEAD OF THE IMPLANT WHILE IT WAS BEING APPLIED TORQUE. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, INFLAMMATION AND DEHISCENCE. AFTER FOLLOW UP, IT WAS REPORTED THAT THE IMPLANT WAS PLACED AND AT THE END WHEN THE TORQUE WAS APPLIED, SHE PUSHED A LITTLE TOO MUCH AND IT WAS THEN WHEN SHE NOTICED THAT THE IMPLANT FRACTURED AT THE UPPER PART. ANOTHER IMPLANT WAS PLACED IN THE SAME SURGERY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604735 EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH DENTAL IMPLANT DZE ZIMMER DENTAL CT3111 1233123 00889024343887

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR