BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 4.1, 10, MTXF, MG,HA

    MDR report key: 23862844 · Received December 22, 2025

    Report

    Report Number
    0001038806-2025-04062
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 21, 2025
    Report Date
    February 3, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024344198
    PMA / PMN Number
    K133339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVT4H10, (IMP, TSV, 4.1, 10, MTXF, MG,HA), FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, SHOWS SIGNS OF WEAR DUE TO USAGE HOWEVER NO DAMAGE IDENTIFIED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1241666. 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 1241666 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT/COOB WAS UNCONFIRMED FOLLOWING FUNCTIONAL TESTING AND PHYSICAL EVALUATION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID NOT OCCUR. SIGNS OF WEAR DUE TO USAGE HOWEVER NO DAMAGE IDENTIFIED AT THE DRIVE FEATURE. THE REPORTED EVENT IS UNCONFIRMED. 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. 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. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RETAINING SCREW MALFUNCTIONED AND NO LONGER CLOSES. TOOTH #31. THE DOCTOR SUSPECTS THE INTERNAL SCREW OF THE FIXTURE MAY BE DEFECTIVE. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

    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
    1661737 IMP, TSV, 4.1, 10, MTXF, MG,HA DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1241666 00889024344198

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male