BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 15463298 · Received September 22, 2022

    Report

    Report Number
    0001038806-2022-01471
    Event Type
    Malfunction
    Date Received
    September 22, 2022
    Date of Event
    August 15, 2022
    Report Date
    February 15, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT; B5: DESCRIBE EVENT OR PROBLEM; D4: ADDITIONAL DEVICE INFORMATION; G3: DATE RECEIVED BY MANUFACTURER; G6: TYPE OF REPORT; H1: TYPE OF REPORTABLE EVENT; H2: FOLLOW UP TYPE ; H3: DEVICE EVALUATED BY MANUFACTURER; H4: DEVICE MANUFACTURER DATE; H6: ADVERSE EVENT PROBLEM; H10: ADDITIONAL NARRATIVE. A CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE AND A FRACTURES AT THE HEAD. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE COMPLAINT. THE REPORTED DEVICE LOCATION IS #35 AND LENGTH OF USAGE IS APPROXIMATELY. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1220518). 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 NUMBER FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE SCREW. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    DOCTOR REPORTED SCREW FRACTURE AT TOOTH SITE 35. PLACEMENT DATE: (B)(6) 2018.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2502744 CERTAIN® GOLD-TITE® HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1220518 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male