BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø3.5 X 10 MM

    MDR report key: 23305310 · Received October 15, 2025

    Report

    Report Number
    3011649314-2025-01280
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    July 21, 2025
    Report Date
    March 17, 2026
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED. THE INVESTIGATION HAS BEEN COMPLETED, AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS THE DHR WAS REVIEWED FOR HAHN TAPERED IMPLANT LOT# 6113526 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 A REVIEW OF STOCK PRODUCT WAS PERFORMED FOR HAHN TAPERED IMPLANT LOT# 6113526 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS THE DEVICE WAS RETURNED BUT NOT IN THE ORIGINAL PACKAGE. THE IMPLANT APPEARED TO BE FRACTURE AS A PART OF THE IMPLANT WAS MISSING. THE THREADS WERE INTACT, BUT IT WAS OBSERVED THAT THE THREADS WERE DENTED. MATTER WAS OBSERVED IN THE TREADING OF THE IMPLANT. ROOT CAUSE DESCRIPTION A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. PROBABLE ROOT CAUSE IS THE OVER-TORQUING OF THE ABUTMENT HOLDING THE CROWN TO THE IMPLANT DURING PLACEMENT WHICH MAY HAVE CAUSED A FRACTURE OVER TIME. ADDITIONALLY, IT IS UNCLEAR THE METHODS OF PLACEMENT USED DURING THE INITIAL PROCEDURE AND THE INSERTION TORQUE VALUE. IFU-570 REV 3 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE RECOMMENDED TORQUE VALUES SECTION: "THE RECOMMENDED TORQUE VALUE FOR AFFIXING HAHN TAPERED IMPLANT ABUTMENTS AND MULTI-UNIT ABUTMENTS TO HAHN TAPERED IMPLANTS IS 35 NCM. THE RECOMMENDED TORQUE VALUE FOR AFFIXING HAHN TAPERED IMPLANT MULTI-UNIT ACCESSORIES UTILIZING THE MULTI-UNIT PROSTHETIC SCREW IS 15 NCM. ANY OTHER SCREW-RETAINED PROSTHETIC COMPONENTS, SUCH AS IMPRESSION COPINGS OR SCAN BODIES, SHOULD BE HAND-TIGHTENED ONLY." THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. HOWEVER, 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

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS II, AND THEIR ORAL HYGIENE IS GOOD. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #4. THE PATIENT RETURNED ON (B)(6) 2025, AFTER THE DELIVERY OF THE PROSTHESIS/ABUTMENT. UPON EXAMINATION, THE PROVIDER NOTED THAT THE PATIENT SWALLOWED THE CROWN. THE IMPLANT BROKE ALONG WITH THE ABUTMENT SCREW. THE PATIENT HAS TO GO TO THE ORAL SURGEON FOR THE REMOVAL OF A BROKEN IMPLANT AND A BONE GRAFT PLACED ON (B)(6) 2025. THEY PLAN TO REPLACE IT IN (B)(6) 2024. NO PERMANENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99559 HAHN TAPERED IMPLANT Ø3.5 X 10 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0005 6113526

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention