BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø5.0 X 10 MM

    MDR report key: 19715757 · Received July 10, 2024

    Report

    Report Number
    3011649314-2024-00479
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    May 21, 2024
    Report Date
    June 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
    AZ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A6, E1, G1, H6 CAPA CA-00016 MANUFACTURER REFERENCE: COMP-(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. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. 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 RETURNED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR HAHN TAPERED IMPLANT LOT# 6120948 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# 6120948 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø5.0 X 10 MM (70-1154-IMP0015) 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. IT WAS ALSO OBSERVED THAT SMALL AREAS OF THE OUTER LAYER WERE STRIPPED OFF, EXPOSING THE INNER LAYER OF THE IMPLANT WHICH WAS LIGHT GRAY. ROOT CAUSE: 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 INITIAL 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HAHN TAPERED IMPLANT FAILED. THE PATIENT HAS A MEDICAL HISTORY OF PERIODONTITIS, BRUXISM, AND SMOKING. ON (B)(6) 2024 THE PATIENT PRESENTED FOR A PRIMARY PROCEDURE ON TOOTH #30. ON (B)(6) 2024, BEFORE THE SECOND STAGE OF SURGERY, THE PATIENT PRESENTED WITH THE FRACTURED IMPLANT. ON (B)(6) 2024 THE PROVIDER REMOVED THE DEVICE AND REPLACED IT WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352137 HAHN TAPERED IMPLANT Ø5.0 X 10 MM HAHN TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0015 6120948

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention