BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD-TITE SQUARE UNISCREW

    MDR report key: 11271367 · Received February 3, 2021

    Report

    Report Number
    0001038806-2021-00162
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    July 30, 2020
    Report Date
    June 4, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE GOLD-TITE® SQUARE UNISCREW (UNISG) WITH CROWN AND ABUTMENT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED SCREW IDENTIFIED FRACTURED AT THE NECK. ALSO, BASE OF THE RETURNED UNKNOWN LB ABUTMENT IDENTIFIED TO HAVE SIGNS OF WEAR. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCTS IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE (UNISG) 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. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENTS 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 HE PLACED AN IMPLANT BNET511 IN (B)(6) 2015. ON (B)(6) 2020 THE DOCTOR REPORTED FRACTURE OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171400 GOLD-TITE SQUARE UNISCREW DENTAL IMPLANT NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1