BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 3.7MM MTX FULL,11.5MM

    MDR report key: 23388826 · Received October 27, 2025

    Report

    Report Number
    0001038806-2025-02690
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    March 21, 2025
    Report Date
    November 27, 2025
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019003
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. D3: EMAIL ADRESS. G1: CONTACT OFFICE - FIRST/GIVEN NAME, LAST NAME AND EMAIL ADDRESS. G1: CONTACT OFFICE - MANUFACTURER SITE - EMAIL ADDRESS. 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) TMTB11, (IMP TM 3.7MM MTX FULL,11.5MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE IMPLANT HAD SIGNS OF USE. THERE WAS NO DAMAGE IDENTIFIED OR SIGNS OF MALFUNCTION THAT WOULD HAVE CONTRIBUTED TO THE EVENT. MEASUREMENTS MATCH DRAWING. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1221558. 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 1221558 FOR SIMILAR EVENTS AND 1 OTHER RELEVANT COMPLAINT(S) WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL: MEDICAL: ALLERGIC REACTION.¿ 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 NOT OCCUR. NO DAMAGE TO THE IMPLANT WAS IDENTIFIED. THE REPORTED EVENT WAS NON-VERIFIABLE. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER: UNKNOWN / NOT PROVIDED. A2: AGE AT TIME OF THE EVENT: UNKNOWN / NOT PROVIDED. D10: CONCOMITANT MEDICAL PRODUCT: TMTB11, IMP TM 3.7MM MTX FULL,11.5MM, LOT: 1221558.

    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 IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #14 & #16 FAILED DUE TO AN ALLERGIC REACTION. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2794480 IMP TM 3.7MM MTX FULL,11.5MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1221558 00889024019003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DENTAL IMPLANT.