BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 11866303 · Received May 21, 2021

    Report

    Report Number
    0001038806-2021-00889
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Report Date
    September 24, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    A CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) WAS NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. ALSO, AN ASSOCIATED PRODUCT IEDAT4 HAS NOT BEEN RETURNED. HOWEVER, THIS ITEM IS LISTED AS ASSOCIATED ITEM ONLY AND DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. NO FURTHER INVESTIGATION WILL BE CONDUCTED.NO PRE-EXISTING CONDITIONS WERE NOTED ON THE COMPLAINT. THE REPORTED DEVICE LOCATION AND USAGE LENGTH IS UNKNOWN. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1243065). 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 COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE (1243065) DATING BACK TO 12 MONTHS FROM NOW . THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW LOOSENED IN THE PATIENTS MOUTH. TOOTH LOCATION NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763152 CERTAIN GOLD-TITE HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1243065 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention