BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø4.3 X 10 MM

    MDR report key: 18166526 · Received November 18, 2023

    Report

    Report Number
    3011649314-2023-00735
    Event Type
    Injury
    Date Received
    November 18, 2023
    Date of Event
    September 16, 2023
    Report Date
    December 3, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. HOWEVER, THE NON-VISUAL DEVICE EVALUATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR HAHN TAPERED IMPLANT LOT# 6101789 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# 6101789 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: CUSTOMER DID NOT RETURN THE REPORTED DEVICE FOR REVIEW TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE: "LOSS OF OSSEOINTEGRATION" IS A COMMON COMPLAINT IN REGARD 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 LOSS OF OSSEOINTEGRATION 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. PREMATURE LOADING, PATIENT'S HEALTH, PERI-IMPLANTITIS, SMOKING, AND LACK OF ORAL HYGIENE MAY ALSO BE CONTRIBUTING FACTORS. IFU 570 REV 3.0 (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 3.0 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN PRECAUTION SECTION SURGICAL PROCEDURES: "MINIMIZING TISSUE DAMAGE IS CRUCIAL TO SUCCESSFUL IMPLANT OSSEOINTEGRATION. IN PARTICULAR, CARE SHOULD BE TAKEN TO ELIMINATE SOURCES OF INFECTION, CONTAMINANTS, SURGICAL AND THERMAL TRAUMA. RISK OF OSSEOINTEGRATION FAILURE INCREASES AS TISSUE TRAUMA INCREASES. FOR BEST RESULTS, PLEASE OBSERVE THE FOLLOWING PRECAUTIONS: ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL, COPIOUS IRRIGATION. ALL SURGICAL INSTRUMENTS USED MUST BE IN GOOD CONDITION AND SHOULD BE USED CAREFULLY TO AVOID DAMAGE TO IMPLANTS OR OTHER COMPONENTS. 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 3.0 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN WARNING SECTION: "ABSOLUTE SUCCESS CANNOT BE GUARANTEED. FACTORS SUCH AS INFECTION, DISEASE AND INADEQUATE BONE QUALITY AND/OR QUANTITY CAN RESULT IN OSSEOINTEGRATION FAILURES FOLLOWING SURGERY OR INITIAL OSSEOINTEGRATION.". IFU 570 REV 3.0 (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.". CORRECTION - B1.ADVERSE EVENT , B.2. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE, B.5. DESCRIBE EVENT OR PROBLEM. ADDITIONAL INFORMATION: H.4. DEVICE MANUFACTURE DATE. THIS FILE IS LINKED TO MDR 3011649314-2023-00734.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. ONCE THE DEVICE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: E1, H6 (HEALTH EFFECT - IMPACT CODE, MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION), H10. CORRECTED INFORMATION: B2, B5, G1, H6 (INVESTIGATION CONCLUSIONS). A4 WAS INADVERTENTLY REPORTED AS 00 IN THE INITIAL REPORT, HOWEVER, THE PATIENTS WEIGHT WAS NOT REPORTED. D6B WAS INADVERTENTLY REPORTED AS (B)(6)2023 IN THE INITIAL REPORT, HOWEVER, THE COMPLAINT DEVICE WAS NOT EXPLANTED. CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE HAHN TAPERED IMPLANT FAILED ON TOOTH #23. PER THE REPORTED INFORMATION THERE ARE NO PREEXISTING MEDICAL CONDITIONS. THE PATIENT PRESENTED FOR A PRIMARY PROCEDURE ON (B)(6) 2022. THE PATIENT'S BONE QUALITY IS TYPE II AND THE PATIENT'S ORAL HYGIENE STATUS IS NOT REPORTED. PATIENT RETURNED ON (B)(6) 2023 FOR FINAL PROSTHESIS DELIVERY AND WITH COMPLAINTS OF PAIN AND TENDERNESS AROUND IMPLANT, UPON EXAMINATION THE PROVIDER NOTICED THE IMPLANT LOST OSSEOINTEGRATION AND THE DEVICE WAS REMOVED AND NOT REPLACED. THE PATIENT'S SYMPTOMS RESOLVED AFTER IMPLANT REMOVAL AND AWAITING IMPLANT REPLACEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATE. THE PATIENT PRESENTED WITH THE ISSUE ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #23. THE IMPLANT WAS PLACED ON (B)(6) 2022 AND EXPLANTED THE SAME DAY ON (B)(6) 2023. PATIENT EXPERIENCED PAIN/TENDERNESS AROUND THE IMPLANT. PATIENT'S SYMPTOMS HAVE RESOLVED AND WAITING TO REPLACE THE IMPLANT.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE HAHN TAPERED IMPLANT FAILED ON TOOTH #23. PER THE REPORTED INFORMATION THERE ARE NO PREEXISTING MEDICAL CONDITIONS. THE PATIENT PRESENTED FOR A PRIMARY PROCEDURE ON (B)(6)2022. THE PATIENT'S BONE QUALITY IS TYPE II AND THE PATIENT'S ORAL HYGIENE STATUS IS NOT REPORTED. PATIENT RETURNED ON (B)(6)2023 AFTER FINAL PROSTHESIS DELIVERY WITH COMPLAINTS OF PAIN AND TENDERNESS AROUND IMPLANT. THE PATIENT PRESENTED WITH THE IMPLANT ALREADY OUT WHEN ARRIVING AT THE CLINIC. THE PROVIDER REPORTED THE IMPLANT WAS MOBILE AND LOST OSSEOINTEGRATION; THE DEVICE WAS NOT REPLACED. THERE WAS NO INFECTION AND THE PATIENT'S SYMPTOMS RESOLVED AND AWAITING IMPLANT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916669 HAHN TAPERED IMPLANT Ø4.3 X 10 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0010 6101789

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention| O