BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 13980919 · Received April 1, 2022

    Report

    Report Number
    0001038806-2022-00490
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Report Date
    September 2, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ONE CERTAIN® BELLATEK® TIN ABUTMENT 3.4MM, ISAN3 & ONE CERTAIN® GOLD-TITE® HEXED SCREW, IUNIHG WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION VIA NAKED EYE AND CAMERA MAGNIFICATION CONFIRMED THAT THE SCREW WAS FRACTURED AT THE THREADS. DAMAGE WAS IDENTIFIED TO THE SCREW ACCESS CHAMBER, HEX CONNECTION AND INTERFACE OF THE ABUTMENT.DAMAGE TO SCREW ACCESS CHAMBER LIKELY CAUSED DURING SCREW REMOVAL. AS THE IMPLANT REMAINS IMPLANTED. THEREFORE, VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION WAS PERFORMED USING APPLICABLE INSTRUCTIONS FOR USE AND RISK FILES TO ADDRESS REPORTED EVENT. THE ABUTMENT WAS SEATED ON A STOCK 3.4MM CERTAIN® IMPLANT WITHOUT HINDRANCE. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE COMPLAINT. THE REPORTED DEVICE WAS LOCATED ON TOOTH #7 WHEN THE EVENT OCCURRED. X-RAY PROVIDED OF IMPLANT IDENTIFIED FRACTURED FRAGMENT OF SCREW INSIDE IMPLANT. . APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (8552814-1). 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. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1234134). 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 CONDUCTED FOR THE SUBJECT LOT NUMBER (1234134) AND REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE SCREW). JUNE POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (FRACTURE SCREW) AND DEVICE (IUNIHG). BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED FOLLOWING INSPECTION AND EVALUATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP". H3: CHANGED "NO" TO "YES".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CLINICIAN SENT EMAIL WITH X-RAY AND ALSO STATED THAT THE SCREW WAS FRACTURED IN THE IMPLANT. TOOTH LOCATION NOT REPORTED.

    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
    1227994 CERTAIN® GOLD-TITE® HEXED SCREW DENTAL IMPLANT NHA BIOMET 3I IUNIHG 1234134 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose