BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 11793959 · Received May 7, 2021

    Report

    Report Number
    0001038806-2021-00771
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    February 22, 2021
    Report Date
    August 26, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CERTAIN® GOLD-TITE® HEXED SCREW, IUNIHG 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 AND LOT NUMBERS. THREE LOOSENING EVENTS WERE REPORTED. THIS INVESTIGATION ADDRESSES THE FIRST EVENT. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICES AND REPORTED EVENTS. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE DEVICE WAS INTENDED FOR TOOTH POSITION #18 (UNIVERSAL) 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 (1241371 - IUNIHG). 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 WAS CONDUCTED FOR THE SUBJECT LOT NUMBER (1241371) FOR SIMILAR EVENTS USING COMPLAINT CATEGORY KEYWORD : LOOSENING. TWO SIMILAR EVENT WERE IDENTIFIED. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION OF THE IUNIHG COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT SCREW FOR THE IMPLANT AT TOOTH SITE #18 WAS LOOSE. THE SCREW WAS RETIGHTENED. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686335 CERTAIN GOLD-TITE HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1241371 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention