BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H)

    MDR report key: 11219178 · Received January 22, 2021

    Report

    Report Number
    0001038806-2021-00109
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Report Date
    April 15, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868004684
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY DEVICE EVALUATION AND ADDITIONAL INFORMATION. THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED EVENT IS UNCONFIRMED FOLLOWING INSPECTION AND EVALUATION. BASED ON THE EVALUATION, THE DEVICE MALFUNCTION HAS NOT OCCURRED. ADDITIONALLY, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED DEVICE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE LIKELY WITHIN SPECIFICATIONS AND LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1241390). 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 (1241390) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT AND THE COMPLAINT IS RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICE. 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 ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH UNKNOWN/NOT PROVIDED. PATIENT SEX UNKNOWN/NOT PROVIDED. WEIGHT UNKNOWN/NOT PROVIDED. DATE OF EVENT UNKNOWN/NOT PROVIDED. FAX NUMBER UNKNOWN/NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALING ABUTMENT WOULD NOT SEAT. DOCTOR PLACED ONE-PIECE HEALING ABUTMENT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108859 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) DENTAL ABUTMENT NHA BIOMET 3I IEHA464 1241390 00844868004684

    Patients

    Seq Age Sex Outcome Treatment
    1