BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 12710516 · Received October 28, 2021

    Report

    Report Number
    0001038806-2021-02077
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    August 23, 2021
    Report Date
    March 25, 2022
    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). 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. SIGNS OF USE AND DAMAGE WERE OBSERVED AT THE DRIVE FEATURE OF THE SCREW, LIKELY DUE TO PROCESS OF SCREW REMOVAL. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1243886). 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 (1243886) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: SCREW FRACTURE ) AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    DOCTOR REPORTED SCREW FRACTURE AT TOOTH SITE 46. SCREW WAS PLACED ON (B)(6) 2010. SCREW WAS REMOVED WITH REMOVAL KIT AND A NEW SCREW WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612315 CERTAIN® GOLD-TITE® HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1243886 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female