BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H)

    MDR report key: 11210998 · Received January 21, 2021

    Report

    Report Number
    0001038806-2021-00095
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 22, 2020
    Report Date
    April 19, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K092341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE REPORTED DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED PRODUCTS IDENTIFIED FRACTURE ACROSS THE THREADS. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS FRACTURED. NO PRE-EXISTING CONDITIONS WERE REPORTED. THE REPORTED DEVICES HAD BEEN PLACE ON TOOTH # 27 FOR APPROXIMATELY 5 MONTHS. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. DHR REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS UNKNOWN. HOWEVER, ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. A YEAR-LONG COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS PERFORMED FOR SIMILAR EVENTS AND NO COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. COMPLAINANT REPORTED THAT THE ABUTMENT FRACTURED. THE REPORTED COMPLAINT WAS CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'

    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

    DESCRIBE EVENT OR PROBLEM IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF LOOSE MANDIBLE HYBRID, REMOVED HYBRID TO FIND FRACTURED ABUTMENT. IT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103042 CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) ABUTMENT NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1