BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø7.0 X 11.5 MM

    MDR report key: 18209731 · Received November 27, 2023

    Report

    Report Number
    3011649314-2023-00315
    Event Type
    Injury
    Date Received
    November 27, 2023
    Date of Event
    March 27, 2023
    Report Date
    July 22, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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 LOT#6120958 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: THERE WAS NO STOCK PRODUCT FROM LOT#6120958 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT 7.0 X 11MM (70-1154-IMP0021) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. BONE DEBRIS WAS OBSERVED IN THE THREADING OF THE IMPLANT, 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 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 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 INFORMATION: H6 (HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSION) CORRECTED INFORMATION: B5, E1, G1 (MEDICAL DEVICE PROBLEM CODE) CAPA CA-00016 MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: E1. THE DEVICE INVESTIGATION HAS BEEN UPDATED AND THE RESULTS ARE AS FOLLOWS: STOCK PRODUCT REVIEWED RESULTS THE STOCK PRODUCT FOR HAHN TAPERED IMPLANT LOT# 6120958 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 Ø7.0 X 11.5 MM (70-1154-IMP0021) 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: "FAILURE TO OSSEOINTEGRATE" 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 FAILURE TO OSSEOINTEGRATE 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 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE SURGICAL PROCEDURES UNDER THE PRECAUTION SECTION: "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 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE 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." CAPA CA-00016: MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS II, AND THEIR ORAL HYGIENE IS LISTED AS EXCELLENT. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #2. THE PATIENT RETURNED ON (B)(6) 2023 WITHIN THREE WEEKS OF IMPLANT PLACEMENT, WITH COMPLAINTS OF PAIN. UPON EXAMINATION, THE PROVIDER NOTED INFLAMMATION, INFECTION, AND GRANULATION/ FIBROUS TISSUE AROUND THE IMPLANT. BASED ON THE DATES NOTED IN THE QUESTIONNAIRE COMPLETED BY THE PROVIDER, A MEDICAL OPINION WAS SOUGHT, AND IT WAS DETERMINED THAT BECAUSE THE IMPLANT WAS PLACED AND REMOVED IN SUCH A SHORT TIME, IT LACKED STABILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS II, AND THEIR ORAL HYGIENE IS LISTED AS EXCELLENT. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH POSITIONS #2 AND #3. THE PATIENT RETURNED ON (B)(6) 2023 WITHIN THREE WEEKS OF IMPLANT PLACEMENT, WITH COMPLAINTS OF PAIN. UPON EXAMINATION, THE PROVIDER NOTED INFLAMMATION, INFECTION, AND GRANULATION/ FIBROUS TISSUE AROUND THE IMPLANT. THE IMPLANT WAS REMOVED AT THAT TIME AND NOT REPLACED. THE SYMPTOMS RESOLVED AFTER IMPLANT REMOVAL AND THE PATIENT HAD NO PERMANENT INJURY. NO ADDITIONAL MEDICAL/SURGICAL PROCEDURE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230422 HAHN TAPERED IMPLANT Ø7.0 X 11.5 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0021 6120958

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention