BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 10763764 · Received October 30, 2020

    Report

    Report Number
    0001038806-2020-01701
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Report Date
    January 13, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION WAS PERFORMED USING APPLICABLE INSTRUCTIONS FOR USE, RISK FILES AND OTHER AVAILABLE INFORMATION. FUNCTIONAL TESTING WAS NOT PERFORMED SINCE THE PRODUCT WAS NOT RETURNED. NO PRE-EXISTING CONDITIONS WERE REPORTED. THE REPORTED DEVICE HAD BEEN PLACED ON AN UNKNOWN TOOTH LOCATION FOR AN UNKNOWN AMOUNT OF TIME. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1223834). 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 (1223834) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENT COULD NOT BE VERIFIED AS THE PRODUCT WAS NOT RETURNED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G7: CHECKED "FOLLOW-UP."

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. EVENT DATE: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED. DEVICE DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABUTMENT SCREW (IUNIHG) HEAD WAS FRACTURED. PATIENT NOTICED THAT CROWN WAS LOOSE AND FRACTURE SCREW WAS DISCOVERED. FRACTURED SCREW WAS REMOVED AND DISCARDED. TOOTH SITE 29.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225122 CERTAIN GOLD-TITE HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I 1223834

    Patients

    Seq Age Sex Outcome Treatment
    1