BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9890302 · Received March 27, 2020

    Report

    Report Number
    0001038806-2020-00586
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) (EHA444)WAS NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 14. X-RAY IMAGES WERE PROVIDED BY THE CUSTOMER. THE X-RAY IMAGE SHOWS THE PRODUCT NOT SEATING IN THE IMPLANT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1200101). 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 (1200101) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. MARCH 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 OCCUR AND THE REPORTED EVENT WAS CONFIRMED. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION AND RISK REVIEW, THE MOST LIKELY CAUSE FOR THE REPORTED EVENT IS CUSTOMER ERROR FOR DEBRIS INTERFERENCE ON SEATING SURFACE, IMPROPER HEALING ABUTMENT SCREW TORQUE AND CLINICIAN DOES NOT FOLLOW THE RECOMMENDED PROTOCOL FOR PRODUCT PLACEMENT. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: UNIQUE IDENTIFIER (UDI) NUMBER. D4: EXPIRATION DATE. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. 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 (B)(4) PATIENT WEIGHT: NOT PROVIDED. EVENT DATE: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED. DEVICE REMAINS IN PATIENT'S MOUTH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALING ABUTMENT (EHA444) COULD NOT SEAT INTO THE IMPLANT. DOCTOR TRIED TO FORCE THE HEALING ABUTMENT DOWN. HEALING ABUTMENT WAS LEFT IN THE PATIENT MOUTH. TOOTH LOCATION 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355101 BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) HEALING ABUTMENT NHA BIOMET 3I 1200101

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR