BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ BELLATEK¿ ENCODE¿ HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H)

    MDR report key: 17133105 · Received June 15, 2023

    Report

    Report Number
    0001038806-2023-01157
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    March 29, 2023
    Report Date
    December 10, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868004554
    PMA / PMN Number
    K072642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) IEHA353, (CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H)) AND ONE (1) XIITP4313 (OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THERE WAS SIGNS OF USE. THERE WAS DEBRIS ON THE IMPLANTS EXTERNAL THREADS. THE ABUTMENT WAS ATTACHED TO THE IMPLANT AND COULD NOT BE REMOVED. THE ABUTMENTS DRIVE FEATURE WAS DAMAGED ALONG WITH THE ABUTMENT ITSELF. THIS COMPLAINT REFERS TO THE IEHA353. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1240846. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1240846 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : FUNCTIONAL : DAMAGED DRIVE FEATURE¿ THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RM-00057-HAZ, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS MISSING OR CONFUSING INSTRUCTIONS FOR USE AND TORQUE APPLIED DURING PLACEMENT/SEATING EXCEEDS RECOMMENDED VALUE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE ABUTMENTS DRIVE FEATURE WAS DAMAGED AND COULD NOT BE DISENGAGED FROM THE IMPLANT. THE REPORTED EVENT WAS CONFIRMED. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    CUSTOMER REPORTED DENTIST CALL TO LET US KNOW THAT HE WAS UNABLE TO REMOVED ENCODE HEALING ABUTMENT. WHEN PATIENT ARRIVED TO THE OFFICE, ENCODE CAP WAS STRIP AND IMPLANT NEEDED TO BE REMOVED. TOOTH 8. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, UNCOVERING OF NEW IMPLANT. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: YES, SAME BRAND IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956998 CERTAIN¿ BELLATEK¿ ENCODE¿ HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) DENTAL ABUTMENT NHA BIOMET 3I IEHA353 1240846 00844868004554

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Prefer Not To Disclose Required Intervention