BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 8708665 · Received June 18, 2019

    Report

    Report Number
    0001038806-2019-00521
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    A CERTAIN® GOLD-TITE® HEXED SCREW (ITEM # IUNIHG) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCTS IDENTIFIED NO VISIBLE SIGNS OF SIGNIFICANT DAMAGE OR DEFORMATION IN EITHER PRODUCT. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICES BEING A SINGLE USE DEVICE & EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER THAT COULD CONTRIBUTE TO THE REPORTED EVENT. THE REPORTED DEVICES WERE LOCATED ON TOOTH # 37 (UNIVERSAL NOTATION) AND WERE IN PLACE FOR AN UNSPECIFIED PERIOD OF TIME. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1201466). 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 (LOT # 1201466) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. JULY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (SCREW LOOSENING) OR DEVICES (IUNIHG). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTIONS COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH AN INCOMPLETE PRODUCT EXPERIENCE FORM (B)(6) 2019) EVENT DESCRIPTION WAS PROVIDED ON (B)(6) 2019.

    Description of Event or Problem · 1

    THE DOCTOR INDICATED THAT THE ABUTMENT SCREW HAS LOOSENED. THERE WAS NO REPORTED ADVERSE EVENT RELATED TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503271 CERTAIN® GOLD-TITE® HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I 1201466

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR