BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 13400925 · Received January 31, 2022

    Report

    Report Number
    0001038806-2022-00124
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Report Date
    July 12, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ONE CERTAIN® GOLD-TITE® HEXED SCREW, IUNIHG WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION WAS PERFORMED USING APPLICABLE INSTRUCTIONS FOR USE AND RISK FILES TO ADDRESS REPORTED EVENT. 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 AND NO PER FORM WAS PROVIDED. THE REPORTED DEVICE WAS LOCATED ON AN UNKNOWN TOOTH SITE AND WAS USED FOR AN UNKNOWN AMOUNT OF TIME. PICTURE/X-RAYS: PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: 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 FUNCTIONAL CAPABILITY. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1241272). 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 WAS CONDUCTED FOR THE SUBJECT LOT NUMBER (1241272) AND REVEALED THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENTS. COMPLAINT CATEGORY KEYWORDS : FRACTURE SCREW. POST MARKET TREND REVIEW: APRIL 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 COULD NOT BE VERIFIED AS THE EXACT DETAILS OF THE THE REPORTED EVENT WAS NON-VERIFIABLE AND THE PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IUNIHG SCREW FRACTURED IN PATIENTS MOUTH. THEY WERE ABLE TO REMOVE THE BROKEN PORTION FROM THE IMPLANT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116838 CERTAIN® GOLD-TITE® HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I IUNIHG 1241272 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 Male