BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)

    MDR report key: 15152301 · Received August 2, 2022

    Report

    Report Number
    0001038806-2022-01173
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    June 23, 2022
    Report Date
    December 9, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868004646
    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). PATIENT WEIGHT NOT PROVIDED CONTACT NAME AND EMAIL ADDRESS OF REPORTER NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE ASSOCIATED SCREW FOR A HEALING ABUTMENT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED FRACTURE AROUND THE THREADS. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED IN THE PER. THE DEVICE WAS INTENDED FOR TOOTH 36 AND WAS IN PLACE FOR ONLY 6 MONTHS. X-RAY & PICTURE EVALUATION: X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENT REVIEWED: BIOMET 3I RESTORATIVE PRODUCTS IFU (P-IIS086GR) REV F - OCTOBER 2019. INFORMATION IDENTIFIED: WARNINGS AND PRECAUTIONS. PER THE APPLICABLE IFU, BREAKAGE/DEVICE FAILURE MAY OCCUR FOLLOWING IMPROPER TECHNIQUES USED AND WHEN DEVICE IS LOADED BEYOND ITS FUNCTIONAL CAPABILITY. DHR REVIEW: DHR REVIEW FOR THE LOT (1253781) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCE'S WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1253781) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE: SCREW) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALING ABUTMENT SCREW FRACTURED AT THE SITE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719352 CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) HEALING ABUTMENT NHA BIOMET 3I IEHA454 1253781 00844868004646

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male