BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSV¿ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 5.0MM (P) X 5MM (H)

    MDR report key: 12295212 · Received August 9, 2021

    Report

    Report Number
    0001038806-2021-01464
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Report Date
    December 9, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868040927
    PMA / PMN Number
    K173374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4109, 4111, 4114, 4110 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 67. H10: NARRATIVE/DATA WAS UPDATED. THE TSV¿ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 5.0MM (P) X 5MM (H) (TEHA3505) WAS NOT RETURNED FOR INVESTIGATION. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE AS THE DEVICE WAS NOT RETURNED. PATIENT PRE-EXISTING CONDITION, TOOTH LOCATION AND DURATION OF IMPLANT ARE UNKNOWN DUE TO LIMITED INFORMATION PROVIDED BY CUSTOMER. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1242102. 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 BY LOT NUMBER (1242102) WAS PERFORMED FOR SIMILAR EVENTS USING KEYWORD (DOES NOT SEAT) AND NO COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS OR PRODUCT (TEHA3505). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NON-VERIFIABLE AND THE PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT DEVICE: UNKNOWN BIOMET IMPLANT, LOT# UNKNOWN /NOT AVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. LOCATION OF DEVICE UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE HEALING ABUTMENT DID NOT SEAT IN THE IMPLANT. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER HEALING ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193143 TSV¿ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 5.0MM (P) X 5MM (H) DENTAL ABUTMENT NHA BIOMET 3I TEHA3503 1242102 00844868040927

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DENTAL IMPLANT-SEE H10 NARRATIVE