BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø4.3 X 8 MM

    MDR report key: 24069983 · Received January 14, 2026

    Report

    Report Number
    3011649314-2026-00039
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    October 15, 2025
    Report Date
    March 5, 2026
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9. THE INVESTIGATION HAS BEEN UPDATED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR HAHN TAPERED IMPLANT LOT #6122573 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: THE STOCK PRODUCT FOR HAHN TAPERED IMPLANT LOT #6122573 WAS REVIEWED AND FOUND TO BE IN STOCK, BUT IT IS NOT APPLICABLE FOR PHYSICAL EVALUATION SINCE THE ISSUE IS CUSTOMER RELATED. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN THE ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø4.3 X 8 MM (70-1154-IMP0009) USING THE RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. MATTER WAS OBSERVED IN THE TREADING OF THE IMPLANT. THE COMPLAINT IS VERIFIED BASED ON THE RETURNED PART BUT CANNOT CONFIRM THE FAILURE MODE. THERE WAS NO EVIDENCE FOUND THAT INDICATED THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE COULD NOT BE EXPLICITLY DETERMINED. A POTENTIAL ROOT CAUSE FOR THIS MAY BE DUE TO AN UNDER PREPARED OSTEOTOMY CAUSING THE IMPROPER PLACEMENT OF THE IMPLANT WHICH COULD HAVE CAUSED THE IMPLANT TO BE ONLY 3MM INTO THE RIDGE. MANUFACTURER REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS NOT YET BEEN RETURNED. AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. MANUFACTURER REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENTS BONE TYPE WAS REPORTED AS TYPE II AND THE ORAL HEALTH AS GOOD. THE PATIENT PRESENTED FOR IMPLANT PLACEMENT ON TOOTH POSITION #19 ON (B)(6) 2025. ON (B)(6) 2025, AFTER THE HEALING ABUTMENT PLACEMENT, THE PATIENT PRESENTED WITH BONE LOSS AND GRANULATION/FIBROUS TISSUE AROUND THE IMPLANT. THE DOCTOR REPORTED THAT THE IMPLANT WAS ONLY 3 MM INTO THE ALVEOLAR RIDGE AND REQUIRED REMOVAL. THE REPORTED DEVICE WAS EXPLANTED ON (B)(6) 2026. THE PATIENT HAD NO PERMANENT INJURY, THERE WAS NO REPLACEMENT PLACED, AND NO ADDITIONAL MEDICAL/SURGICAL PROCEDURE WAS REQUIRED. THE PROVIDER WHO PERFORMED THE EXPLANT WAS NOT THE SAME PROVIDER WHO PLACED THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560715 HAHN TAPERED IMPLANT Ø4.3 X 8 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0009 6122573

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention