BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H)

    MDR report key: 13042197 · Received December 20, 2021

    Report

    Report Number
    0001038806-2021-02405
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    September 30, 2021
    Report Date
    May 2, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868004639
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER: (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G3: DATE RECEIVED BY THE MANUFACTURER. H1: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE. ONE HEALING ABUTMENT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO SIGN OF MALFUNCTION/DAMAGE. THE PRODUCT WAS RETURNED OUTSIDE OF THE ORIGINAL PACKAGING WHICH CONFIRMED THAT THE PACKAGING WAS ALREADY OPENED BY THE CUSTOMER. FUNCTIONAL TESTING WAS PERFORMED WITH AN IN-HOUSE IMPLANT. THE PRODUCT WAS ABLE TO SEAT ONTO THE IMPLANT AS INTENDED (FILE: FUNCTIONAL TEST). PATIENT PRE-EXISTING CONDITIONS, TOOTH LOCATION, PLACEMENT DURATION AND X-RAY IMAGE WERE IRRELEVANT TO THIS INVESTIGATION. PICTURE EVALUATION: PICTURE IMAGE WAS NOT PROVIDED BY THE CUSTOMER. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: BIOMET 3I RESTORATIVE PRODUCTS IFU (P-IIS086GR) REV F ¿ OCTOBER 2019. INFORMATION IDENTIFIED: WARNINGS AND PRECAUTIONS IMPROPER TECHNIQUES CAN LEAD TO DEVICE FAILURE. DHR REVIEW: DHR REVIEW FOR THE LOT: (1241335) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES 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. THE DHR WAS FURTHER REVIEWED TO VERIFY THE PRODUCT RELEASE INFORMATION. NO MALFUNCTION OR NONCONFORMANCE WAS IDENTIFIED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER: (1241335) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORD: FUNCTIONAL: DOES NOT SEAT) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: FEBRUARY 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 NOT OCCUR. THE REPORTED EVENT HAS BEEN UNCONFIRMED AND THE COOB COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEFECT IN THE PRODUCT AS IT DID NOT CLICK .THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942694 CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) DENTAL ABUTMENT NHA BIOMET 3I IEHA453 1241335 00844868004639

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown