BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAHN TAPERED IMPLANT Ø3.5 X 10 MM

    MDR report key: 24318911 · Received February 11, 2026

    Report

    Report Number
    3011649314-2026-00224
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 13, 2026
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHYSICAL DEVICE WAS RECEIVED. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE RESULTS ARE AS FOLLOWS: DHR RESULTS THE DHR WAS REVIEWED FOR LOT#6201827 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 WAS NO STOCK PRODUCT FROM LOT#6201827 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS CUSTOMER HAS NOT RETURNED THE REPORTED DEVICE FOR REVIEW TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE DESCRIPTION A ROOT CAUSE CANNOT BE EXPLICITLY DETERMINED. IT IS UNKNOWN OF THE CUSTOMER FOLLOWED INSTRUCTIONS IN IFU-570. IFU-570 REV 4.0 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN PRECAUTION SECTION SURGICAL PROCEDURES: "MINIMIZING TISSUE DAMAGE IS CRUCIAL TO SUCCESSFUL IMPLANT OSSEOINTEGRATION. IN PARTICULAR, CARE SHOULD BE TAKEN TO ELIMINATE SOURCES OF INFECTION, CONTAMINANTS, SURGICAL AND THERMAL TRAUMA. RISK OF OSSEOINTEGRATION FAILURE INCREASES AS TISSUE TRAUMA INCREASES. ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL AND COPIOUS IRRIGATION. ALL SURGICAL INSTRUMENTS USED MUST BE IN GOOD CONDITION AND SHOULD BE USED CAREFULLY TO AVOID DAMAGE TO IMPLANTS OR OTHER COMPONENTS. IMPLANTS SHOULD BE PLACED WITH SUFFICIENT STABILITY; HOWEVER, EXCESSIVE INSERTION TORQUE MAY RESULT IN IMPLANT FRACTURE, OR FRACTURE OR NECROSIS OF THE IMPLANT SITE. THE PROPER SURGICAL PROTOCOL SHOULD BE STRICTLY ADHERED TO." PER THE REPORTED INFORMATION, THE PATIENT IS A SMOKER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. THE EVALUATION OF THE DEVICE IS PENDING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER'S INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS II, AND THEIR ORAL HYGIENE IS LISTED AS FAIR. THE PATIENT PRESENTED ON (B)(6) 2024 FOR A PRIMARY PROCEDURE ON TOOTH #4. THE PATIENT RETURNED ON (B)(6) 2026, AFTER THE FINAL PROSTHESIS DELIVERY, WITH COMPLAINTS OF PAIN. UPON EXAMINATION, THE PROVIDER NOTED THAT INFLAMMATION AND ABNORMAL BONE LOSS AROUND THE IMPLANT HAD OCCURRED, AND THE DEVICE WAS FRACTURED (2 YEARS LATER). THE DEVICE WAS REMOVED AND NOT REPLACED. BONE GRAFTING WAS DONE, AND NO PERMANENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375787 HAHN TAPERED IMPLANT Ø3.5 X 10 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0005 6201827

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention