BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11251044 · Received January 29, 2021

    Report

    Report Number
    0001038806-2021-00138
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    December 23, 2020
    Report Date
    April 21, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) (IEHA454) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE. NO DAMAGE. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT WITH AN IN-HOUSE STOCK DEVICE AND PERFORMED AS INTENDED. NO MALFUNCTION IDENTIFIED. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE LENGTH OF THE DEVICE USAGE IS SAME DAY. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1230119). 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 (1230119) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE PROBABLE CAUSES ARE NOT APPLICABLE TO THE REPORTED EVENT SINCE THE DEVICE MALFUNCTION DID NOT OCCUR AND THE EVENT IS UNCONFIRMED THROUGH VISUAL AND PHYSICAL INSPECTION. NO FURTHER INVESTIGATION AND NO IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. EVENT DATE: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALING ABUTMENT DID NOT FULLY SEAT INTO THE IMPLANT. HEALING ABUTMENT SEEMS TO BE SMALLER. DOCTOR COMPLETED THE PROCEDURE USING ANOTHER HEALING ABUTMENT FROM STOCK AND IT SAT NORMALLY. TOOTH LOCATION 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151892 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) HEALING ABUTMENT NHA BIOMET 3I 1230119

    Patients

    Seq Age Sex Outcome Treatment
    1