BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 8713225 · Received June 19, 2019

    Report

    Report Number
    0001038806-2019-00547
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Report Date
    October 28, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCTS IDENTIFIED FRACTURES OF SCREW NEAR THE BASE OF SCREW. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICE WAS LOCATED ON TOOTH #8 AND WAS USED FOR APPROXIMATELY 3 YEAR. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1192410). 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 WERE 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 # 1192410) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. JUNE POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (SCREW FRACTURE) OR DEVICE (IUNIHG). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A FRACTURED SCREW (IUNIHG). IMPLANT REMAINS IMPLANTED. NO ADDITIONAL SURGICAL INTERVENTION OR INJURY HAS BEEN REPORTED. TOOTH LOCATION 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505410 CERTAIN® GOLD-TITE® HEXED SCREW SCREW NHA BIOMET 3I 1192410

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR