BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T3® PRO TAPERED IMPLANT 5/4MM (D) X 10MM (L)

    MDR report key: 24595224 · Received March 13, 2026

    Report

    Report Number
    0001038806-2026-01373
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    December 29, 2025
    Report Date
    April 3, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00844868046769
    PMA / PMN Number
    K213672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) T3PT5410, (T3® PRO TAPERED IMPLANT 5/4MM (D) X 10MM (L)) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, APPARENT BONE / TISSUE ATTACHED TO EXTERNAL THREADS AND WAS OBSERVED ATTACHED TO AN ENCODE ABUTMENT. NO ALLEGATIONS WERE REPORTED AGAINST THE ENCODE ABUTMENT AND NO APPARENT MALFUNCTION WAS IDENTIFIED. THE IMPLANT WAS IDENTIFIED AS REPORTED HOWEVER, NO APPARENT MALFUNCTION WAS IDENTIFIED WITH THE IMPLANT THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. IMPLANT MATCHED PRINTS WHERE MEASURED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2120021311. 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 2120021311 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE CUSTOMER DID SUBMIT TEN (10) X-RAY IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE INADEQUATE TREATMENT PLANNING, AND PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE IMPLANT MALFUNCTION DID NOT 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D9: DEVICE AVAILABILITY. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H11: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAUSE FOR THE FAILED IMPLANT WAS PATIENT'S MEDICAL CONDITION OF SCLERODERMA. THE CLINICIAN PLACED THE IMPLANT ON SITE #3 ON (B)(6) 2025 WITH NO ISSUES. ON (B)(6) 2025 PATIENT RETURNED TO THE OFFICE FOR POST OP APPT. AT FIRST POST OPERATIVE APPOINTMENT FOLLOWING DENTAL IMPLANT PROCEDURE FOUND DENTAL IMPLANT 3 LOST PRIMARY STABILITY DESPITE INITIAL GREAT STABILITY AT 50-55 NCM AND PAIN TO ROTATION WITH HAND DRIVER. IN THIS APPT DOC SAW THE IMPLANT WAS NOT INTEGRATED SO HE TRIED SCREWING IT DEEPER TO SEE IF IT WOULD INTEGRATE. COULD NOT GET DENTAL IMPLANT TO RE-ESTABLISH STABILITY BY SEATING MORE APICAL. REMOVED. BONE FOUND ATTACHED TO IMPLANT THREADS - COMPLICATION DUE TO SEVERE CASE OF SCLERODERMA. AFTER THAT DOC SAW THE IMPLANT WAS STILL NOT INTEGRATED SO HE REMOVED IT. HE CAME TO THE CONCLUSION THE IMPLANT FAILED DUE TO HER MEDICAL CONDITION AS THAT CAN CAUSE BONE LOSS. THE PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT, REMOVED FAILED IMPLANT, PLACED REGENEROSS CONE COMPRESSED INTO OSTEOTOMY, THEN MINIMIZED EXPLANT SITE AND SECURED REGENEROSS WITH 2, 4-0 CG SUTURES.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415898 T3® PRO TAPERED IMPLANT 5/4MM (D) X 10MM (L) DENTAL IMPLANT DZE ZIMVIE US CORP LLC 2120021311 00844868046769

    Patients

    Seq Age Sex Outcome Treatment
    1