BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 10906757 · Received November 25, 2020

    Report

    Report Number
    0001038806-2020-01902
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 29, 2020
    Report Date
    February 24, 2021
    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

    A CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG), CERTAIN® BELLATEK® TITANIUM ABUTMENT 5.0MM (IEDAT5) AND UNK 3I IMPLANT WERE NOT RETURNED. SINCE PRODUCTS HAVE 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 DEVICE WAS LOCATED ON TOOTH # 30 AND WAS USED FOR APPROXIMATELY 2 YEARS 8 MONTHS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1212237). 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 NUMBERS (1212237) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENTS ARE NON-VERIFIABLE. NO FURTHER INVESTIGATION AND NO IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT WEIGHT: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABUTMENT SCREW HAD LOOSENED WITHIN THE DENTAL IMPLANT AT TOOTH LOCATION 30. ABUTMENT SCREW WAS UNSCREWED AND REMOVED. IMPLANT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371243 CERTAIN GOLD-TITE HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I 1212237

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR