BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX,10MM

    MDR report key: 22881911 · Received August 25, 2025

    Report

    Report Number
    0002023141-2025-02320
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    March 12, 2025
    Report Date
    October 15, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018808
    PMA / PMN Number
    K132258
    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). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K113753/K112160.

    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) TMM4B10, (IMP TM 4.1MM MTX,10MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE IMPLANT HAD SIGNS OF USE. THE IMPLANT WAS FRACTURED AT THE BODY. THE FRACTURED PIECE WAS NOT RETURNED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1273166. 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 1273166 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 CUSTOMER ERROR - RECOMMENDED PROTOCOL WAS FOLLOWED DURING PLACEMENT/SEATING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE IMPLANT WAS FRACTURED AT THE BODY. 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 IN POSITION 25 FAILED DUE TO A FRACTURE AT THE APICAL THIRD DURING THE SURGICAL PROCEDURE. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. THE REST OF THE IMPLANT WAS REMOVED FROM PATIENT'S MOUTH

    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
    2823404 IMP TM 4.1MM MTX,10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1273166 00889024018808

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown