BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 8523523 · Received April 17, 2019

    Report

    Report Number
    0001038806-2019-00331
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    December 20, 2018
    Report Date
    July 5, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CERTAIN® GOLD-TITE® HEXED SCREW (IUNIHG) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AT THE SCREW BODY, THREADS, AND DRIVE FEATURE. THE ITEM IS NOT NOTED TO BE FRACTURED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1220161. 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 1220161 FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT(S) (SCREW FRACTURE) OR DEVICE(S) (IUNIHG). THEREFORE, BASED ON THE EVALUATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED FOLLOWING INSPECTION. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED; HOWEVER, THE PROBABLE CAUSES ARE NOT APPLICABLE TO THE REPORTED EVENT SINCE THE DEVICE MALFUNCTION DID NOT OCCUR AND THE EVENT IS UNCONFIRMED THROUGH VISUAL AND PHYSICAL INSPECTION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE RETURNED DEVICE WAS IDENTIFIED AS IUNIHG GOLD-TITE SCREW.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED A SUSPECTED FRACTURE OF AN UNKNOWN GOLD SCREW. IMPLANT REMAINS IMPLANTED. TOOTH LOCATION 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314488 CERTAIN® GOLD-TITE® HEXED SCREW GOLD SCREW NHA BIOMET 3I 1220161

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR