BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø3.5 X 10 MM

    MDR report key: 18940926 · Received March 20, 2024

    Report

    Report Number
    3011649314-2024-00170
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    February 8, 2024
    Report Date
    April 10, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE EVALUATION OF THE DEVICE IS PENDING. AT THE COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE ANALYSIS CONCLUSION. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED; DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PROBABLE OR ROOT CAUSE OF THE EVENT HAS NOT BEEN IDENTIFIED. MANUFACTURER'S INTERNAL REFERENCE NUMBER: COMP (B)(4).

    Additional Manufacturer Narrative · 0

    CAPA CA-00016. CAPA 24-005. MANUFACTURER'S INTERNAL REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION HAS BEEN COMPLETED; FOLLOWING IS THE DEVICE ANALYSIS CONCLUSION: DHR RESULTS: THE DHR WAS REVIEWED FOR HAHN TAPERED IMPLANT LOT#: 6140080 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. (DONE ON 03/01/2024 C. NGUYEN 05/09/2024). STOCK PRODUCT REVIEWED RESULTS: THE STOCK PRODUCT FOR HAHN TAPERED IMPLANT LOT#: 6140080 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED. C. NGUYEN 05/09/2024. INVESTIGATION METHODS/RESULTS: BASED ON THE TRACKING LABEL THE PRODUCT WAS NOTED TO HAVE BEEN RECEIVED AND IN GLIDEWELL'S POSSESSION; HOWEVER, TO DATE THE DEVICE HAS NOT BEEN PHYSICALLY ACCOUNTED FOR AND SENT TO THE COMPLAINT'S TEAM FOR ANALYSIS. THEREFORE, IT IS PRESUMED LOST AT THIS TIME, CAPA: 2024-005 WAS OPENED FOR RMA LOST PRODUCT. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. C. NGUYEN 05/09/2024. 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 4 (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 (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 4 (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." IFU 570 REV 4 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE 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." C. NGUYEN 05/09/2024.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED A HAHN TAPERED IMPLANT FAILED TO OSSEOINTEGRATE WITHIN THREE WEEKS OF PLACEMENT ON TOOTH NUMBER 19. IT WAS REPORTED THAT THE PATIENT OBSERVED THE FOLLOWING SYMPTOMS: INFLAMMATION, PAIN, INFECTION, AND IMPLANT WAS EXPOSED. THE DEVICE WAS REMOVED AND WAS NOT REPLACED; HOWEVER, A BONE GRAFT PROCEDURE WAS PERFORMED FOR FUTURE PLACEMENT. THE SYMPTOMS WERE RESOLVED WITHOUT PERMANENT INJURY. IT WAS REPORTED THAT AT THE TIME OF THE SURGICAL PROCEDURE THE PATIENT'S BONE QUALITY WAS TYPE III WITH GOOD ORAL HYGIENE STATUS.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT A HAHN TAPERED IMPLANT FAILED TO OSSEOINTEGRATE WITHIN THREE WEEKS OF PLACEMENT ON TOOTH NUMBER 19. IT WAS REPORTED THAT THE PATIENT OBSERVED THE FOLLOWING SYMPTOMS: INFLAMMATION, PAIN, INFECTION, AND THE IMPLANT WAS EXPOSED. THE DEVICE WAS REMOVED AND WAS NOT REPLACED; HOWEVER, A BONE GRAFT PROCEDURE WAS PERFORMED FOR FUTURE PLACEMENT. THE SYMPTOMS WERE RESOLVED WITHOUT PERMANENT INJURY. IT WAS REPORTED THAT AT THE TIME OF THE SURGICAL PROCEDURE, THE PATIENT'S BONE QUALITY WAS TYPE II, AND THE PATIENT HAD GOOD ORAL HYGIENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436610 HAHN TAPERED IMPLANT Ø3.5 X 10 MM HAHN TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0005 6140080

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention