BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ UCLA CASTABLE NON-HEXED CYLINDER 4.1MM(D) W/LARGE DIA. TI SCREW

    MDR report key: 16217953 · Received January 20, 2023

    Report

    Report Number
    0001038806-2023-00092
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    December 28, 2022
    Report Date
    May 9, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868008521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED. PATIENT WEIGHT UNKNOWN / NOT PROVIDED. ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. REPORTER NAME AND ADDRESS AND EMAIL UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION UNKNOWN / NOT PROVIDED. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4) THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. ONE SCREW WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE AND A FRACTURES AT THE THREADS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE COMPLAINT. THE REPORTED DEVICE LOCATION IS #45 AND LENGTH USAGE IS UNKNOWN. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: BIOMET 3I RESTORATIVE PRODUCTS IFU (P-IIS086GR) REV F ¿ OCTOBER 2019 INFORMATION IDENTIFIED: 'WARNINGS' 'PRECAUTIONS' 'POTENTIAL ADVERSE EVENTS'. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1230451). 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 (1230451) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TREND REVIEW: FEB POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCREW AT TOOTH SITE 45 FRACTURED AT THE THREADS OF THE SCREW AND WAS REMOVED.

    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
    1051877 CERTAIN¿ UCLA CASTABLE NON-HEXED CYLINDER 4.1MM(D) W/LARGE DIA. TI SCREW DENTAL SCREW DZE BIOMET 3I IUNAB2T 1230451 00844868008521
    688491 CERTAIN¿ UCLA CASTABLE NON-HEXED CYLINDER 4.1MM(D) W/LARGE DIA. TI SCREW DENTAL SCREW DZE BIOMET 3I IUNAB2T 1230451 00844868008521

    Patients

    Seq Age Sex Outcome Treatment
    1 Male