BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø3.5 X 10 MM

    MDR report key: 21658372 · Received March 20, 2025

    Report

    Report Number
    3011649314-2025-00229
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    February 24, 2025
    Report Date
    October 8, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED, 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 IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø3.5 X 10 MM (70-1154-IMP0005) 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 PROBABLE ROOT CAUSE IS THAT THE METHODS OF THE PROCEDURES WERE NOT PROPERLY FOLLOWED WHERE THE MINIMUM TORQUE VALUE WAS NOT OBTAINED. IT IS UNKNOWN THE METHODS OF IMPLANT PLACEMENT USED DURING THE INITIAL PROCEDURE AND THE INSERTION TORQUE VALUE. IFU-570 REV 4 (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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT A HAHN IMPLANT HAS FAILED. ON (B)(6) 2025 THE PATIENT PRESENTED FOR A PRIMARY PROCEDURE ON TOOTH #13. DURING IMPLANT PLACEMENT, THE IMPLANT DIDN'T TORQUE IN PROPERLY AND WAS LOOSE. THE IMPLANT WAS REMOVED AND 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
    368186 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 84 YR Female Required Intervention