BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK® ABUTMENT TSV 3.5MM

    MDR report key: 24496649 · Received March 3, 2026

    Report

    Report Number
    0001038806-2026-01113
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NHA
    UDI-DI
    00844868037965
    PMA / PMN Number
    K071439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER - (B)(6). A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. A3: PATIENT SEX UNKNOWN / NOT PROVIDED. A4: WEIGHT UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K143505. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ABUTMENT/CROWN LOOSENED AFTER BEING PLACED. THE ABUTMENT/CROWN WAS SWALLOWED BY THE PATIENT. A NEW SCAN WAS SENT TO REMAKE THE ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281801 BELLATEK® ABUTMENT TSV 3.5MM DENTAL ABUTMENT NHA ZIMVIE US CORP LLC 1110028307 00844868037965

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown