BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 8741916 · Received June 27, 2019

    Report

    Report Number
    0001038806-2019-00594
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Report Date
    October 24, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) WAS NOT RETURNED FOR INVESTIGATION. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 10 (UNIVERSAL) AND USED FOR AN UNKNOWN PERIOD OF TIME. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1211484. 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 (1211484) FOR SIMILAR CAUSE 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 FRACTURE) OR PRODUCT (IUNIHG). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. 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

    ADDITIONAL INFORMATION RECEIVED REPORT THE SCREW WAS UNABLE TO BE REMOVED. IMPLANT REMAINS IMPLANT AND DOCTOR PLANNING TO DO A BRIDGE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE ABUTMENT SCREW FRACTURED AND THE FRACTURED SCREW IS STILL WITHIN IMPLANT. THE SCREW IS PENDING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534855 CERTAIN® GOLD-TITE® HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I 1211484

    Patients

    Seq Age Sex Outcome Treatment
    1