BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø3.5 X 10 MM

    MDR report key: 21415208 · Received February 19, 2025

    Report

    Report Number
    3011649314-2025-00129
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    January 15, 2025
    Report Date
    October 16, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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# 6201830 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# 6201830 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 SIZE OF THE IMPLANT COULD NOT BE VERIFIED AS THE IMPLANT WAS RETURNED FRACTURED. A DENTAL PROSTHETIC WAS ALSO RETURNED. THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. 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 IMPLANT DURING THE INITIAL PLACEMENT WHICH MAY HAVE CAUSED A FRACTURE. ADDITIONALLY, IT IS UNCLEAR THE METHODS OF IMPLANT PLACEMENT USED DURING THE PROCEDURE AND THE INSERTION TORQUE VALUE. IFU-570 REV 3 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE IMPLANT PLACEMENT SECTION: "STEP 3: ADVANCEMENT AND FINAL SEATING - CONTINUE THREADING THE IMPLANT INTO THE OSTEOTOMY SITE USING THE PREFERRED PLACEMENT METHOD. A MINIMUM TORQUE VALUE OF 35 NCM UPON FINAL SEATING INDICATES GOOD PRIMARY STABILITY." IFU-570 REV 3 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE PRECAUTIONS SECTION: "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." IFU-570 REV 3 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE RECOMMENDED TORQUE VALUES SECTION UNDER PROSTHETIC COMPONENTS: "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 SCANNING ABUTMENTS, SHOULD BE HAND-TIGHTENED ONLY." THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. ONCE THE RETURNED DEVICE HAS BEEN EVALUATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT A HAHN IMPLANT FAILED. THE PATIENT'S BONE QUALITY TYPE IS I AND ORAL HYGIENE IS GOOD. ON (B)(6) 2024 THE PATIENT PRESENTED FOR A PRIMARY PROCEDURE ON TOOTH #30. ON (B)(6) 2025, AFTER THE FINAL PROSTHESIS DELIVERY THE IMPLANT FRACTURED AT THE NECK. ON (B)(6) 2025 THE IMPLANT WAS REMOVED AND WAS NOT REPLACED. NO PERMANENT INJURY WAS REPORTED. PER THE REPORTED INFORMATION, THERE WERE NO PREEXISTING MEDICAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379780 HAHN TAPERED IMPLANT Ø3.5 X 10 MM HAHN TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0005 6201830

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention