BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 5MM(H)

    MDR report key: 23713693 · Received December 4, 2025

    Report

    Report Number
    0001038806-2025-03539
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    October 29, 2025
    Report Date
    February 23, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NHA
    UDI-DI
    00844868045762
    PMA / PMN Number
    K212730
    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). D10: CONCOMITANT MEDICAL PRODUCT: TEEHA355, TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 5MM(H), LOT: 1301092. E1: REPORTER NAME: UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) TEEHA355, (TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 5MM(H)) FOR EVALUATION. UPS SHIPMENT HAS BEEN LOST IN TRANSIT WHEN THE PRODUCT WAS SHIPPED FOR INVESTIGATION. A CLAIM HAS BEEN PLACED. IF UPS LOCATES THE SHIPMENT, THE COMPLAINT WILL BE RE-OPENED AND UPDATED ACCORDINGLY. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1301092. 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 1301092 FOR SIMILAR EVENTS AND 1 OTHER RELEVANT COMPLAINT(S) WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : FIT : DOES NOT SEAT¿ BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS CUSTOMER ERROR, APPLYING TO MUCH TORQUE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. THE REPORTED EVENT IS 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.

    Description of Event or Problem · 0

    THE DOCTOR REPORTED THAT THE TWO ABUTMENTS DO NOT SEAT PROPERLY. NO IMPACT TO THE PATIENT.

    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
    1892079 TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 5MM(H) DENTAL HEALING ABUTMENT NHA ZIMVIE US CORP LLC 1301092 00844868045762

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male DENTAL HEALING ABUTMENT SEE H10 NARRATIVE