BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 15190515 · Received August 9, 2022

    Report

    Report Number
    0001038806-2022-01217
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Date of Event
    November 24, 2020
    Report Date
    January 3, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ONE CERTAIN® GOLD-TITE® HEXED SCREW, UNIHG & ONE CERTAIN® BELLATEK® TITANIUM ABUTMENT 3.4MM, ILDAT3 WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL INSPECTION VIA NAKED EYE AND CAMERA MAGNIFICATION COULD NOT BE PERFORMED AND THE INVESTIGATION WILL BE OF THE AVAILABLE INFORMATION OF THE ITEM/LOT NUMBER, RISK MANAGEMENT FILES AND IFU. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED. NO PRE-EXISTING CONDITIONS WERE REPORTED AND A PER WAS NOT PROVIDED. THE DEVICE WAS INTENDED FOR TOOTH POSITION #14 AT THE TIME OF THE REPORTED EVENT. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED . DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1221045). 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. A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1221045) FOR SIMILAR EVENTS AND REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (LOOSENING) OR PRODUCT (IUNIHG). BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION OF THE IUNIHG COULD NOT BE VERIFIED BUT THE REPORTED EVENT WAS CONFIRMED VIA IMAGE PROVIDED BY THE CUSTOMER. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP". H3: CHANGED "YES" TO "NO". H10: ADDED MANUFACTURER NARRATIVE H3 OTHER TEXT : DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW LOOSENED IN THE PATIENTS MOUTH. THE SCREW WAS RETIGHTENED TO 20 NCM . NO INDICATION OF DAMAGED ABUTMENT IN THE PATIENTS CHART. BELIEVES IT MAY BE DAMAGED BECAUSE THE LOOSENING EVENTS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942332 CERTAIN® GOLD-TITE® HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1221045 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male