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: 9289954 · Received November 7, 2019

    Report

    Report Number
    0001038806-2019-01313
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Report Date
    January 24, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    A CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H (IEHA453) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE HOWEVER NO DAMAGE. THE RETURNED DEVICE WAS MEASURED WITH A CALIPER (B)(4). CAL DUE: SEP 25, 2020) AND VERIFIED TO MATCH DHR SPECIFICATIONS PER DWG NO. 222024 REV M. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT WITH AN IN-HOUSE STOCK IMPLANT AND IT WAS DETERMINED THAT THE ABUTMENT SEATED AND HAND TIGHTENED AS INTENDED. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE TOOTH LOCATION AND LENGTH OF IMPLANTATION IS UNKNOWN. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1221472). 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 (1221472) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT DOES NOT SEAT AND DEVICE (IEHA453) . BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: UNIQUE IDENTIFIER (UDI) NUMBER. D4: EXPIRATION DATE. D10: DEVICE AVAILABILITY. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H4: MANUFACTURER DATE. H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALING ABUTMENT (IEHA453) COULD NOT SEAT. ANOTHER HEALING ABUTMENT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087334 CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) HEALING ABUTMENT NHA BIOMET 3I 1221472

    Patients

    Seq Age Sex Outcome Treatment
    1