BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø3.5 X 8 MM

    MDR report key: 17908906 · Received October 10, 2023

    Report

    Report Number
    3011649314-2023-00584
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    August 22, 2023
    Report Date
    June 2, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED. AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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#6130163 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#6130163 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø3.5 X 8 MM (70-1154-IMP0004) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. THE COMPLAINT IS VERIFIED BASED ON THE RETURNED PART(S) 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: "LACK OF PRIMARY STABILITY" IS A COMMON COMPLAINT IN REGARDS TO IMPLANT FAILURE. THIS OCCURS WHEN THE PATIENT'S BONE DOES NOT INTEGRATE WITH THE IMPLANT SURFACE. THE POSSIBLE RESPONSES TO THIS COMPLAINT COULD BE ATTRIBUTED TO VARIOUS CAUSES. ALTHOUGH THE ROOT CAUSE FOR LACK OF PRIMARY STABILITY IS INCONCLUSIVE AND SPECIFIC TO EACH CASE, PROBABLE CAUSES COULD BE DUE TO INSUFFICIENT BONE OR POOR BONE QUALITY; EITHER THE BONE WAS TOO SOFT OR THE OPERATOR ERRED IN CREATING AN OSTEOTOMY BIGGER THAN THE SIZE OF THE IMPLANT DIAMETER. IFU 570 REV 4.0 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE CONTRAINDICATIONS SECTION: "HAHN TAPERED IMPLANTS SHOULD NOT BE PLACED IN PATIENTS DISCOVERED TO BE MEDICALLY UNFIT FOR THE INTENDED TREATMENT. PRIOR TO CLINICAL INTERVENTION, PROSPECTIVE PATIENTS MUST BE THOROUGHLY EVALUATED FOR ALL KNOWN RISK FACTORS AND CONDITIONS RELATED TO ORAL SURGICAL PROCEDURES AND SUBSEQUENT HEALING. CONTRAINDICATIONS INCLUDE BUT ARE NOT LIMITED TO: VASCULAR CONDITIONS, UNCONTROLLED DIABETES, CLOTTING DISORDERS, ANTICOAGULANT THERAPY, METABOLIC BONE DISEASE, CHEMOTHERAPY OR RADIATION THERAPY, CHRONIC PERIODONTAL INFLAMMATION, INSUFFICIENT SOFT TISSUE COVERAGE, METABOLIC OR SYSTEMIC DISORDERS ASSOCIATED WITH WOUND AND/OR BONE HEALING, USE OF PHARMACEUTICALS THAT INHIBIT OR ALTER NATURAL BONE REMODELING, ANY DISORDERS WHICH INHIBIT A PATIENT'S ABILITY TO MAINTAIN ADEQUATE DAILY ORAL HYGIENE, UNCONTROLLED PARAFUNCTIONAL HABITS, INSUFFICIENT HEIGHT AND/OR WIDTH OF BONE, AND INSUFFICIENT INTERARCH SPACE." IFU 570 REV 4.0 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN WARNING SECTION: THE IMPLANT SITE SHOULD BE INSPECTED FOR ADEQUATE BONE BY RADIOGRAPHS, PALPATIONS AND VISUAL EXAMINATION. DETERMINE THE LOCATION OF NERVES AND OTHER VITAL STRUCTURES AND THEIR PROXIMITY TO THE IMPLANT SITE BEFORE ANY DRILLING TO AVOID POTENTIAL INJURY, SUCH AS PERMANENT NUMBNESS TO THE LOWER LIP AND CHIN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: E1, H6. CORRECTED DATA: B5, G1. CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT WAS IMPLANTED ON TOOTH NUMBER 10. PATIENT FIRST PRESENTED WITH THE ISSUE ON (B)(6) 2023. THE PLACEMENT DATE IS (B)(6) 2023. DURING PLACEMENT OF THE DEVICE THERE WAS FAILURE OF OSSEOINTEGRATION. IT WAS EXPLANTED (B)(6) 2023 AND THE IMPLANT WAS NOT REPLACED. PATIENT EXPERIENCED INFLAMMATION, GRANULATIONS/FIBROUS TISSUE AROUND THE IMPLANT AND ABNORMAL BONE LOSS AROUND THE IMPLANT. SYMPTOMS HAVE RESOLVED AFTER THE IMPLANT REMOVAL. BONE QUALITY IS TYPE IV AND ORAL HYGIENE IS GOOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE QUALITY IS TYPE IV AND ORAL HYGIENE IS GOOD. THE DEVICE WAS IMPLANTED ON TOOTH NUMBER 10 ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT RETURNED AND THERE WAS LACK OF PRIMARY STABILITY. IT WAS EXPLANTED (B)(6) 2023 AND THE IMPLANT WAS NOT REPLACED. PATIENT EXPERIENCED INFLAMMATION, GRANULATIONS/FIBROUS TISSUE AROUND THE IMPLANT AND ABNORMAL BONE LOSS AROUND THE IMPLANT. SYMPTOMS HAVE RESOLVED AFTER THE IMPLANT REMOVAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE QUALITY IS TYPE IV, AND ORAL HYGIENE IS GOOD. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #10. ON (B)(6) 2023, THE PATIENT RETURNED, AND UPON EXAMINATION, THE PROVIDER NOTED THAT THE IMPLANT FAILED TO INTEGRATE, AND THE DEVICE WAS REMOVED AND NOT REPLACED. THE PATIENT EXPERIENCED INFLAMMATION, GRANULATIONS/FIBROUS TISSUE, AND ABNORMAL BONE LOSS AROUND THE IMPLANT. THE SYMPTOMS RESOLVED AFTER THE IMPLANT REMOVAL. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL/SURGICAL PROCEDURES, AND NO OTHER PERMANENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347219 HAHN TAPERED IMPLANT Ø3.5 X 8 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0004 6130163

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention