BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 8832881 · Received July 26, 2019

    Report

    Report Number
    0001038806-2019-00776
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    May 6, 2019
    Report Date
    October 31, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE AND WEAR ALONG THE THREADS AND HEX FEATURE, LIKELY FROM THE RE-TIGHTENING OR REMOVAL PROCESS. HOWEVER, FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT (LOOSENING). ADDITIONALLY, THE COMPLAINT DESCRIPTION SUGGESTS THE REPORTED DEVICE WAS RE-VISITED/RE-TIGHTENED AFTER THE FIRST REPORTED LOOSENING EVENT (MAY 6), WHICH GOES AGAINST THE PRODUCT'S SINGLE-USE DESIGNATION AND THE REFERENCED IFU WARNINGS. THE CUSTOMER DID NOT PROVIDE PICTURES OR X-RAY IMAGES. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCES WERE NOTED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1221044) FOR SIMILAR EVENTS AND ONE OTHER COMPLAINT WAS IDENTIFIED. COMPLAINANT REPORTED THAT THE SCREW KEPT LOOSENING AFTER SEVERAL APPOINTMENT APPLYING 20NCM OF TORQUE BETWEEN 04/30/2019 AND 05/6/2019. THE REPORTED COMPLAINT COULD NOT BE VERIFIED BECAUSE THE EVENT CANNOT BE RECREATED AS TESTING OR MEASUREMENT ANALYSIS CAN NOT BE COMPLETED FOR THE LOOSENING EVENT.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). WERE NOT PROVIDED AND ARE UNKNOWN. LOT NUMBER WAS NOT PROVIDED AND THEREFORE IS UNKNOWN. DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAN AN ABUTMENT SCREW HAD LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627508 CERTAIN® GOLD-TITE® HEXED SCREW DENTAL ABUTMENT SCREW NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR