BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,10

    MDR report key: 23400313 · Received October 28, 2025

    Report

    Report Number
    0001038806-2025-02725
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    August 4, 2025
    Report Date
    January 6, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019225
    PMA / PMN Number
    K072589
    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). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, B5: DESCRIBE EVENT OR PROBLEM, G3: DATE RECEIVED BY MANUFACTURER, G6: TYPE OF REPORT, H1: TYPE OF REPORTABLE EVENT, H2: FOLLOW UP TYPE, H3: DEVICE EVALUATED BY MANUFACTURER, H6: ADVERSE EVENT PROBLEM, H10: ADDITIONAL NARRATIVE. ZIMVIE RECEIVED ONE (1) TSV4B10, (IMP, TSV,4.1MM, SBM,10) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, APPARENT BONE / TISSUE ATTACHED TO EXTERNAL THREADS. THE IMPLANT WAS OBSERVED FRACTURED AT THE COLLAR, AND AN IRT TOOL WAS SEEN STUCK INSIDE THE IMPLANT; HOWEVER, DURING A FOLLOW UP THE CUSTOMER CONFIRMED THAT THERE IS NO ISSUE WITH THIS DEVICE, AND THAT IT SIMPLY OCCURRED DURING THE IMPLANT REMOVAL PROCESS. THEREFORE, THE ITEM WILL BE ADDED AS A CONCOMITANT MEDICAL PRODUCT. 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 1232588. 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 1232588 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿FRACTURE IMPLANT¿ BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE PARAFUNCTIONAL HABITS/PATIENT FACTORS, OR CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. 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).

    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 DENTAL IMPLANT LOCATED IN POSITION NUMBER 46 FAILED BECAUSE IT FRACTURED AT THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2735507 IMP,TSV,4.1MM,SBM,10 DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1232588 00889024019225

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention