BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 10167437 · Received June 18, 2020

    Report

    Report Number
    0001038806-2020-00858
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    February 27, 2020
    Report Date
    September 14, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER: (B)(4). A CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED SCREW IDENTIFIED WORN MARKINGS AROUND THE THREADS DUE TO USAGE AND A WEAR ON THE HEX DRIVE FEATURE, POSSIBLY DUE TO THE REMOVAL PROCESS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 24 AND WAS USED FOR APPROXIMATELY 2 YEARS AND 10 MONTHS. X-RAY IMAGES WERE PROVIDED BY THE CUSTOMER, SEE ATTACHED X-RAY IMAGE IN THE COMPLAINT. THE X-RAY IMAGE SHOWS THE PATIENTS MOUTH WITH PRODUCT. ALSO, ACCORDING TO THE IFU, PATIENT FACTORS LIKE PRESENCE OF OCCLUSAL ABNORMALITIES OR PARAFUNCTIONAL HABITS (E.G. SEVERE BRUXISM, CLENCHING, OVERLOADING OR GNAWING) MAY CAUSE SCREW LOOSENING, RESTORATION FRACTURE, AND/OR IMPLANT FAILURE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1202546). 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 (1202546) FOR SIMILAR EVENT AND ONE OTHER RELEVANT COMPLAINT WAS IDENTIFIED:(B)(4) JUNE 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 COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED LOOSENING OF THE SCREW. NEW SCREW HAS BEEN PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631222 CERTAIN GOLD-TITE HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1202546 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR