BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE IMPLANT 4 X 15MM

    MDR report key: 23653908 · Received November 26, 2025

    Report

    Report Number
    0001038806-2025-03406
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    September 19, 2025
    Report Date
    February 25, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    PMA / PMN Number
    K063286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) OSS415 (OSSEOTITE IMPLANT 4 X 15MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED. RETURNED IMPLANT SHOWS EXTENSIVE SIGNS OF WEAR/USE. BONE DEBRIS CAN BE OBSERVED ON ITS EXTERNAL THREADS. FRACTURE IDENTIFIED AT THE COLLAR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 221419 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. 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 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

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D4: UNIQUE IDENTIFIER (UDI) NUMBER NOT AVAILABLE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED AN IMPLANT FRACTURED AT THE COLLAR AT TOOTH SITE #36. IMPLANT WAS COMPLETELY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2620083 OSSEOTITE IMPLANT 4 X 15MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 221419

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention