BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19296711 · Received May 13, 2024

    Report

    Report Number
    0001038806-2024-00963
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 9, 2024
    Report Date
    October 1, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868004608
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) IEHA444, (CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H)) FOR EVALUATION VISUAL EVALUATION WAS PERFORMED, ONLY THE ABUTMENT BODY WAS RETURNED. THE ABUTMENT SCREW WAS NOT RETURNED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1253559. 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 1253559 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : FUNCTIONAL : FRACTURE : SCREW¿ 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 THE TORQUE APPLIED DURING PLACEMENT/SEATING EXCEEDS RECOMMENDED VALUE. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE SCREW WASN¿T RETURNED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. THE RETAINING SCREW WAS NOT RETURNED WITH THE ABUTMENT. THE REPORTED EVENT WAS NON-VERIFIABLE. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H3: CHANGED "YES" TO "NO". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE H3 OTHER TEXT : DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICIAN PLACED HEALING ABUTMENT AND SCREW BROKE OFF INSIDE OF THE IMPLANT. THE SCREW WAS REMOVED AND ANOTHER ENCODE PLACED. TOOTH #3

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858751 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) DENTAL SCREW NHA BIOMET 3I 1253559 00844868004608

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male