BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø4.3 X 10MM

    MDR report key: 17322194 · Received July 13, 2023

    Report

    Report Number
    3011649314-2023-00473
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    July 13, 2022
    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
    NC, 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# 6080940 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# 6080940 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. PER THE REPORTED INFORMATION, THE PATIENT HAS A HISTORY OF ANEMIA, SMOKING, PSORIASIS, ARTHRITIS, PERIODONTAL DISEASE, AND ANXIETY. IFU 570 REV 2.0 (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 2.0 (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. 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 2.0 (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 2.0 (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

    THE DEVICE HAS NOT BEEN RETURNED. IF / WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4). RELATED MW REPORTS: 3011649314-2023-00472. 3011649314-2023-00474. 3011649314-2023-00475.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS IV. THE PATIENT HAS A HISTORY OF ANEMIA, SMOKING, PSORIASIS, ARTHRITIS, PERIODONTAL DISEASE, ANXIETY, FULL-MOUTH EXTRACTIONS, AND IMMEDIATE IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2020 FOR A PRIMARY PROCEDURE ON TOOTH #4. THE PATIENT RETURNED ON (B)(6) 2022 AFTER THE FINAL PROSTHESIS DELIVERY WITH COMPLAINTS OF PAIN. UPON EXAMINATION, THE PROVIDER NOTED INFECTION AND THAT THE PATIENT FAILED TO SHOW UP FOR FOLLOW-UP OR ROUTINE APPOINTMENTS, NOR DID THE PATIENT SHOW UP FOR THE DELIVERY OF THE NIGHT GUARD. IT WAS DETERMINED THAT THE IMPLANT HAD LOST INTEGRATION, AND THE DEVICE WAS REMOVED. THE IMPLANT SITE WAS GRAFTED AND SUTURED FOR HEALING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANTS FAILED. THE PATIENT PRESENTED ON (B)(6) 2020 FOR PLACEMENT ON TOOTH POSITIONS #4 (D4), #7 (D3), # 10 (D3) AND #13 (D4). OSTEOGEN BONE MATERIAL WAS PLACED ON POSITIONS #7 AND 10. THE PATIENT PRESENTED WITH ISSUES OF PAIN ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT DID NOT FOLLOW UP WITH THE DOCTOR AND MISSED MANY APPOINTMENTS INCLUDING NIGHT GUARD DELIVERY. THERE WAS SIGNIFICANT BONE LOSS AND INFECTION. IT WAS DETERMINED THAT THE IMPLANTS HAD A LOSS OF OSSEOINTEGRATION AND THEY WERE REMOVED. THE PROVIDER CURATED SOCKETS TO REMOVE INFECTION, PLACED BONE GRAFT MATERIAL AND SUTURED FOR HEALING. IMPRESSED AND DELIVERED REMOVABLE UPPER DENTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185205 HAHN TAPERED IMPLANT Ø4.3 X 10MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0010 6080940

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention