BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSV BELLATEK ENCODE HEALING ABUTMENT 3.5MM (D) X 3.8MM (P) X 5MM (H)

    MDR report key: 11107947 · Received January 4, 2021

    Report

    Report Number
    0002023141-2021-00009
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    December 11, 2020
    Report Date
    April 21, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    PMA / PMN Number
    K173374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TSV¿ BELLATEK® ENCODE® HEALING ABUTMENT (TEHA3385) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED MINOR SIGNS OF WEAR DUE TO USAGE. THE PRODUCT HAD NO APPARENT SIGNS OF MALFUNCTION. FUNCTIONAL TESTING WAS PERFORMED USING AN APPLICABLE IN-HOUSE IMPLANT. THE DEVICES WERE ABLE TO ASSEMBLE AND DISASSEMBLE AS NORMAL. NO PRE-EXISTING CONDITIONS WERE NOTED. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH # 3 FOR AN UNKNOWN PERIOD OF TIME. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. DHR REVIEW FOR THE LOT (1241090) 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. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (1241090) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. JANUARY 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 AND FUNCTIONAL TESTING, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED. NO FURTHER INVESTIGATION OR 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BELLATEK TSV HEALING ABUTMENT COULD NOT BE PLACED INTO THE IMPLANT; THE HEALING ABUTMENT WOULD JUST KEEP SPINING AND DID NOT ENGAGE THE IMPLANT. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9943 TSV BELLATEK ENCODE HEALING ABUTMENT 3.5MM (D) X 3.8MM (P) X 5MM (H) HEALING ABUTMENT NHA ZIMMER DENTAL 1241090

    Patients

    Seq Age Sex Outcome Treatment
    1