BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ UCLA CASTABLE NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. TI SCREW

    MDR report key: 16553231 · Received March 16, 2023

    Report

    Report Number
    0001038806-2023-00520
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    December 11, 2022
    Report Date
    November 2, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868006558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED TWO (2) IMUCC2T, (CERTAIN UCLA CASTABLE NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. TI SCREW) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE, BOTH SCREWS WERE FRACTURED AT THE THREADS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1212548. 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 1212548 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE SCREW. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS ATTRIBUTED TO PATIENT FACTORS DUE TO PARAFUNCTIONAL HABITS (BRUXISM) OVER THE IMPLANTATION PERIOD. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED. 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. 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). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION UNKNOWN / NOT PROVIDED. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT THE TWO SCREWS HAVE FRACTURED THROUGH/BY THE BODY. THE AFFECTED DENTAL POSITIONS ARE #43 AND #46. THE DOCTOR INDICATES IN THE PER THAT THE PROCEDURE WAS CONCLUDED WITH THE PLACEMENT OF ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455863 CERTAIN¿ UCLA CASTABLE NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. TI SCREW DENTAL ABUTMENT NHA BIOMET 3I 1212548 00844868006558

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Prefer Not To Disclose