BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 12681627 · Received October 22, 2021

    Report

    Report Number
    0001038806-2021-02046
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 3, 2021
    Report Date
    March 22, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE CERTAIN® GOLD-TITE® HEXED SCREW, IUNIHG WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION VIA NAKED EYE AND CAMERA MAGNIFICATION CONFIRMED THAT THE SCREW WAS FRACTURED AT THE HEAD. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. PER: NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER FORM. THE REPORTED DEVICE WAS LOCATED ON TOOTH SITE 35 (FDI) AND WAS USED FOR 4 YEARS AND 4 MONTHS. PICTURE/X-RAYS: 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: 'PRECAUTIONS' 'BREAKAGE' 'WARNING' PER THE APPLICABLE IFU, BREAKAGE MAY OCCUR WHEN DEVICE IS LOADED BEYOND ITS FUNCTIONAL CAPABILITY. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1190913). 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: A LOT SPECIFIC COMPLAINT HISTORY REVIEW NUMBER WAS CONDUCTED FOR THE (IUNIHG). THE REVIEW REVEALED THAT THERE ARE NO EXISTING NONCONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE SCREW) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TREND REVIEW: JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (FRACTURE SCREW) AND DEVICE (IUNIHG ). MALF/EVENT: 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

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. LAST NAME UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    DOCTOR REPORTED THE SCREW FRACTURED IN THE BELLATEK ABUTMENT. IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577046 CERTAIN® GOLD-TITE® HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1190913 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown