BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 3.7MM MTX FULL,10M

    MDR report key: 21633503 · Received March 18, 2025

    Report

    Report Number
    0002023141-2025-00733
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    January 30, 2025
    Report Date
    June 20, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018990
    PMA / PMN Number
    K132258
    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).

    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) TMTB10, (IMP TM 3.7MM MTX FULL,10M), FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED; A FRACTURE HAS BEEN IDENTIFIED ON THE IMPLANTS BODY. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1254129. 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 1254129, 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 CLINICIAN SELECTS IMPLANT THAT IS UNABLE TO RESIST LONG-TERM OCCLUSAL LOADING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE FRACTURE HAS BEEN IDENTIFIED ON 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

    IT WAS REPORTED AN IMPLANT FRACTURED. UPPER PART WAS REMOVED BUT LOWER PART OF THE IMPLANT WAS BURIED AND NEW IMPLANT WILL BE PLACE IN A DIFFERENT POSITION.

    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
    1306144 IMP TM 3.7MM MTX FULL,10M DENTAL IMPLANT DZE ZIMMER DENTAL 1254129 00889024018990

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention