BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 8MM LENGTH

    MDR report key: 14447286 · Received May 19, 2022

    Report

    Report Number
    0002023141-2022-01230
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    January 9, 2022
    Report Date
    October 31, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024343627
    PMA / PMN Number
    K142082
    Removal / Correction Number
    N/A
    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). ONE IMPLANT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO DAMAGE OR SIGNS OF MALFUNCTION THAT WOULD CONTRIBUTE TO THE EVENT. MEASUREMENTS MATCH DRAWING. (B)(6) (DUE: (B)(6), 2022) FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS LOW BONE DENSITY (TYPE IV). THE REPORTED DEVICE WAS INTENDED FOR TOOTH # 12 (FDI) AND WAS NOT USED. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR IMPLANTS, ABUTMENTS AND RESTORATIVE COMPONENTS FOR 3.1MMD EZTETIC¿ IMPLANT IFU 9228 REV. 1 ¿ 11/19. INFORMATION IDENTIFIED: 'CONTRAINDICATIONS' 'WARNINGS' 'PRECAUTIONS' 'ADVERSE EFFECTS'. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1240108). 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1240108) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: 'DAMAGED OR UN-SEALED STERILE BARRIER' POST MARKET TREND REVIEW: AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DAMAGED OR UN-SEALED STERILE BARRIER) OR PRODUCT (CM318). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER VIAL WAS DETERIORATED, IN BAD CONDITION AND IMPLANT WAS BIT PLACED. PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892002 EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 8MM LENGTH DENTAL IMPLANT DZE ZIMMER DENTAL CM318 1240108 00889024343627

    Patients

    Seq Age Sex Outcome Treatment
    1 Male