BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 10582053 · Received September 24, 2020

    Report

    Report Number
    0001038806-2020-01430
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    August 31, 2020
    Report Date
    November 16, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    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 THE APPLICABLE INSTRUCTIONS FOR USE AND RISK FILES. FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED. NO PRE-EXISTING CONDITIONS WERE REPORTED. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH NUMBER 30 FOR APPROXIMATELY 3 YEARS. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. DHR REVIEW FOR THE LOT (1200856) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE LOT (1200856) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. SEPTEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENTS COULD NOT BE VERIFIED SINCE THE PRODUCT WAS NOT RETURNED AND NO PICTORIAL EVIDENCE WAS PROVIDED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABUTMENT SCREW (IUNIHG) FRACTURED WITHIN THE IMPLANT AT POSITION NUMBER 30. NO INJURY WAS REPORTED. FRAGMENT SCREW EXPECTED TO BE REMOVED. IMPLANT REMAINS IMPLANTED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045281 CERTAIN GOLD-TITE HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I 1200856

    Patients

    Seq Age Sex Outcome Treatment
    1