BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 8482724 · Received April 4, 2019

    Report

    Report Number
    0001038806-2019-00273
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    November 16, 2018
    Report Date
    July 9, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) AND WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED FRACTURE AT THE HEAD OF IUNIHG SCREW. SCREW HEAD IS WORN FROM USE. IT IS NOTE THAT THE PATIENT HAS A HISTORY OF BRUXISM. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1101788. 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 1101788 FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT(SCREW FRACTURE) OR DEVICES (IUNIHG). THEREFORE, BASED ON THE EVALUATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED FOLLOWING INSPECTION FOR THE RETURNED PRODUCTS. THE MOST LIKELY CAUSE RELATED TO THE EVENT IS PATIENT BRUXISM. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4), G4: DATE RECEIVED BY MANUFACTURER, G7: CHECKED "FOLLOW-UP", H2: CHECKED FOLLOW-UP TYPE, H3: DEVICE EVALUATED BY MANUFACTURER, H6: ENTERED EVALUATION CODES AND H10: ADDED MANUFACTURER NARRATIVE. THE FOLLOWING SECTIONS HAVE BEEN CORRECTED: B5: TOOTH LOCATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW (IUNIHG) OF A METAL-ACRYLIC FIXED PROTHESIS FRACTURED. FRACTURED SCREW WAS REMOVED. TOOTH LOCATION 26.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW (IUNIHG) OF A METAL-ACRYLIC FIXED PROTHESIS FRACTURED. FRACTURED SCREW WAS REMOVED. TOOTH LOCATION 42.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275023 CERTAIN® GOLD-TITE® HEXED SCREW SCREW NHA BIOMET 3I 1101788

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR