BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE¿ IMPLANT 4 X 13MM

    MDR report key: 22585310 · Received July 24, 2025

    Report

    Report Number
    0001038806-2025-01773
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    October 10, 2024
    Report Date
    October 1, 2025
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). D4: UNIQUE IDENTIFIER (UDI) NUMBER: NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) OSS413, (OSSEOTITE IMPLANT 4 X 13MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE IMPLANT HAD SIGNS OF USE WITH BONE DEBRIS ON THE EXTERNAL THREADS. DAMAGE TO THE IMPLANT WAS IDENTIFIED. THE IMPLANT WAS TREPHINED. THE IMPLANTS COLLAR WAS FRACTURED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 243256. 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 243256 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : FUNCTIONAL : FRACTURE : IMPLANT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS PATIENT FACTORS - OCCLUSAL LOADING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE IMPLANT WAS FRACTURED AT THE COLLAR. 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.

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #46 FAILED BECAUSE IT FRACTURED BY THE HEAD. IMPLANT WAS REMOVED. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187145 OSSEOTITE¿ IMPLANT 4 X 13MM DENTAL IMPLANT DZE BIOMET 3I 243256

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention