BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT 4.3 X 10

    MDR report key: 15671299 · Received October 25, 2022

    Report

    Report Number
    3011649314-2022-00562
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    September 20, 2022
    Report Date
    July 9, 2024
    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 NOT BEEN RETURNED. IF/ WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE 1ST OF 2ND FAILED IMPLANTS REPORTED ON THE SAME PATIENT. REFERENCE THE FOLLOWING MANUFACTURER REPORTS FOR THE REMAINING IMPLANTS: 3011649314-2022-00563.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS THE DHR WAS REVIEWED FOR 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 THE PACKAGED STOCK PRODUCT IS NOT APPLICABLE FOR REVIEW SINCE NO DEFECT WAS OBSERVED FROM THE RETURNED PRODUCT. INVESTIGATION METHODS/RESULTS THE DEVICE WAS RETURNED BUT NOT IN THE ORIGINAL PACKAGE. THE DEVICE WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø4.3 X 10 MM (70-1154-IMP0010) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. SIGNIFICANT BONE DEBRIS WAS OBSERVED ON THE IMPLANT. ROOT CAUSE "LACK OF PRIMARY STABILITY" 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 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. 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 IFU) 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. THE RISK OF OSSEOINTEGRATION FAILURE INCREASES AS TISSUE TRAUMA INCREASES. ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL AND 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 IFU) 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. THE IFU ALSO 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." PER THE REPORTED INFORMATION, THE PATIENT HAD A HISTORY OF HIGH BLOOD PRESSURE AND WAS PRESCRIBED ELIQUIS. IFU 570 REV 3.0 (HAHN TAPERED IMPLANT SYSTEM IFU) 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."

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: H6 (MEDICAL DEVICE PROBLEM CODE - 2933, AND TYPE OF INVESTIGATION CODES). CORRECTED DATA: B3, B5, B7, D1, H6 (MEDICAL DEVICE PROBLEM CODE - 2408). CAPA 23-006. 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 GOOD. THE PATIENT HAS A HISTORY OF HIGH BLOOD PRESSURE AND WAS PRESCRIBED ELIQUIS. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #30. THE PATIENT RETURNED ON (B)(6) 2022 AFTER A ONE MONTH OF PLACEMENT AS THE IMPLANT HAD COME OUT. THE PROVIDER DETERMINED THAT THE IMPLANT HAS LOSS INTEGRATION. BASED ON THE DATES NOTED IN THE QUESTIONNAIRE COMPLETED BY THE PROVIDER, MEDICAL OPINION WAS SOUGHT, AND IT WAS DETERMINED THAT BECAUSE THE IMPLANT WAS PLACED AND REMOVED IN SUCH A SHORT TIME SPAN, THE IMPLANT 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 GOOD. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #30. THE PATIENT RETURNED ON (B)(6) 2022 AFTER A ONE MONTH OF PLACEMENT AS THE IMPLANT HAD COME OUT. THE PROVIDER DETERMINED THAT THE IMPLANT HAS LOST INTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2721099 HAHN TAPERED IMPLANT 4.3 X 10 HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0010 6101789

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention