BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT OPEN-TRAY IMPRESSION COPING 3 MMH - Ø3.5 IMPLANT

    MDR report key: 21539899 · Received March 6, 2025

    Report

    Report Number
    3011649314-2025-00203
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    December 12, 2024
    Report Date
    October 31, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. HOWEVER, THE EVALUATION OF THE DEVICE IS PENDING. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE THIRD OF THREE COMPLAINTS FOR THE SAME PATIENT, RELATED MDR NUMBERS: 3011649314-2025-00201, 3011649314-2025-00202. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN COMPLETED; THE RESULTS ARE AS FOLLOWS: DHR RESULTS. THE DHR WAS REVIEWED FOR LOT#6140588 AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. THE PART MET ALL THE CRITERIA CALLED FOR IN THE PRODUCTION ROUTER. STOCK PRODUCT REVIEWED RESULTS. THERE IS STOCK PRODUCT FOR LOT#6140588 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS. THE RETURNED PRODUCT WAS EVALUATED, AND NO IMPLANT COMPONENTS WERE FOUND STUCK TO THE OPEN-TRAY IMPRESSION COPING. NO OTHER ANOMALIES WERE OBSERVED DURING THE EVALUATION. ROOT CAUSE DESCRIPTION. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATES THAT THE PRODUCT MET ALL SPECIFICATIONS PRIOR TO RELEASE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT A HAHN TAPERED IMPLANT OPEN-TRAY IMPRESSION COPING IMPLANT FAILED. THE PATIENT'S BONE QUALITY IS TYPE IS NOT REPORTED, AND THE PATIENT'S ORAL HYGIENE IS REPORTED AS GOOD. THE PATIENT PRESENTED ON (B)(6) 2024 FOR A PRIMARY PROCEDURE ON TOOTH #5. THE PATIENT RETURNED ON (B)(6) 2024 FOR SECOND STAGE SURGERY, UPON EXAMINATION THE PROVIDER NOTICED THAT THE IMPLANT LACKED PRIMARY STABILITY AND THAT THE IMPLANT WAS STUCK IN CYLINDER AND WAS REMOVED, NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. IMPLANT SITE WAS GRAFTED, AND IMPLANT WILL BE PLACED AFTER INTEGRATION OF BONE GRAFT. PER THE REPORTED INFORMATION THERE ARE NO PREEXISTING MEDICAL CONDITIONS. NO REPORTS OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593830 HAHN TAPERED IMPLANT OPEN-TRAY IMPRESSION COPING 3 MMH - Ø3.5 IMPLANT HAHN TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1153-PRC0029 6140588

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention