BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 6MM(D) 7.5MM(P) 5MM(H)

    MDR report key: 25135365 · Received May 11, 2026

    Report

    Report Number
    0001038806-2026-02590
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    February 20, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NHA
    UDI-DI
    00844868045717
    PMA / PMN Number
    K212730
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN / NOT PROVIDED CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMVIE FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALING ABUTMENT IS NOT ENGAGING INTO THE IMPLANT AT TOOTH SITE #18. DID NOT SEAT EVEN WITH THE PROFILER. ANOTHER HEALING ABUTMENT WAS OPENED AND SEATED WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279844 CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 6MM(D) 7.5MM(P) 5MM(H) DENTAL ABUTMENT NHA ZIMVIE US CORP LLC 4110000265 00844868045717

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female UNKNOWN IMPLANT