BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 8520594 · Received April 16, 2019

    Report

    Report Number
    0001038806-2019-00326
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    March 15, 2019
    Report Date
    May 24, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED STATE THAT IMPLANT WAS REMOVED DUE TO THE FRACTURED SCREW. A CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED NO SIGNS OF SIGNIFICANT WEAR, DAMAGE, OR DEFORMATION. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1222368). 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 # 1222368) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, INCORRECT TECHNIQUE USED OR TORQUE APPLIED DURING PLACEMENT/SEATING EXCEEDS RECOMMENDED VALUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATED THAT FRACTURED SCREW COULD NOT BE REMOVED AND IMPLANT WAS REMOVED ( TREPHINED).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS TRYING TO TIGHTEN A NEW SCREW; THE SCREW (IUNIHG) FRACTURED INSIDE THE IMPLANT. SCREW COULD NOT BE REMOVED AND IMPLANT REMAINS IMPLANTED. TOOTH LOCATION 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311905 CERTAIN® GOLD-TITE® HEXED SCREW SCREW NHA BIOMET 3I 1222368

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR BOST511