BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø7.0 X 10 MM

    MDR report key: 16560255 · Received March 16, 2023

    Report

    Report Number
    3011649314-2023-00156
    Event Type
    Injury
    Date Received
    March 16, 2023
    Date of Event
    December 7, 2022
    Report Date
    May 28, 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

    CAPA 2023-006. THE DEVICE WAS RETURNED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS THE DHR WAS REVIEWED FOR LOT# 6111688 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# 6111168 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 Ø7.0 X 10 MM (70-1154-IMP0020) 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. 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. CORRECTION - B3 DATE OF EVENT, B5 DESCRIBE EVENT OR PROBLEM, D6A IMPLANTED DATE.

    Additional Manufacturer Narrative · 0

    CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES. PATIENT'S RACE IS NOT RECORDED AT THE TIME OF OFFICE VISIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS III, AND THEIR ORAL HYGIENE IS UNKNOWN. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #14. THE PATIENT HAD ISSUES ON (B)(6) 2022 AND RETURNED ON (B)(6) 2022, AT THE SECOND STAGE OF SURGERY, WITHOUT COMPLAINT. UPON EXAMINATION, THE PROVIDER NOTED DEHISCENCE. IT WAS DETERMINED THAT THE IMPLANT LACKED STABILITY, AND THE DEVICE WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS II. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #14. THE PATIENT RETURNED ON (B)(6) 2022 AND UPON EXAMINATION, THE PROVIDER NOTED DEHISCENCE. ON (B)(6) 2022, AT THE SECOND STAGE OF SURGERY, THE PROVIDER DETERMINED THAT THE IMPLANT LACKED STABILITY; THE IMPLANT CAME OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS III, AND THEIR ORAL HYGIENE IS UNKNOWN. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #14. THE PATIENT RETURNED ON (B)(6) 2022, AT THE SECOND STAGE OF SURGERY, WITHOUT COMPLAINT. UPON EXAMINATION, THE PROVIDER NOTED DEHISCENCE. IT WAS DETERMINED THAT THE IMPLANT LACKED STABILITY, AND THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936586 HAHN TAPERED IMPLANT Ø7.0 X 10 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0020 6111688

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention