BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAHN TAPERED IMPLANT Ø5.0 X 16 MM

    MDR report key: 19449178 · Received June 3, 2024

    Report

    Report Number
    3011649314-2024-00349
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    May 8, 2024
    Report Date
    September 18, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS CURRENTLY ONGOING. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. ONCE THE RETURNED DEVICE HAS BEEN EVALUATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    CLARIFICATION OF THE INITIAL LOT NUMBER WAS REQUESTED FROM THE PROVIDER AS IT WAS FOUND THAT THE INITIAL LOT NUMBER DID NOT MATCH THE DIMENSIONS OF THE IMPLANT SIZE THAT WAS INITIALLY REPORTED. A CORRECTED LOT NUMBER (6133057) WAS RECEIVED. THEREFORE, SECTIONS D.1, D.4 AND H.4 WERE ALL CORRECTED TO REFLECT THE CURRENT LOT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HAHN TAPERED IMPLANT HAD A LACK OF PRIMARY STABILITY. THE PATIENT DOES NOT HAVE A RELEVANT MEDICAL OR DENTAL HISTORY. THE PATIENT'S BONE QUALITY IS TYPE IV AND THEIR ORAL HYGIENE IS NOTED AS GOOD. ON (B)(6) 2024, THE PATIENT PRESENTED FOR PRIMARY PROCEDURE ON TOOTH # 14. DURING IMPLANT PLACEMENT, THE PROVIDER DETERMINED THERE WAS A LACK OF PRIMARY STABILITY AND EXPLANTED THE DEVICE. NO PATIENT SYMPTOMS WERE REPORTED BY THE PROVIDER. THE IMPLANT WAS REPLACED WITH A SIMILAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939913 HAHN TAPERED IMPLANT Ø5.0 X 16 MM HAHN TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT INC. 70-1154-IMP0018 6133057

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male