BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø4.3 X 10MM

    MDR report key: 13664403 · Received March 3, 2022

    Report

    Report Number
    3011649314-2022-00043
    Event Type
    Injury
    Date Received
    March 3, 2022
    Date of Event
    September 21, 2021
    Report Date
    January 14, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE 2ND OF 2 FAILED IMPLANTS REPORTED ON THE SAME PATIENT. REFERENCE THE FOLLOWING MANUFACTURER REPORTS FOR THE REMAINING IMPLANTS: 3011649314-2022-00042.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS; THE DHR WAS REVIEWED FOR LOT# 6080437 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 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. ROOT CAUSE; "LOSS OF OSSEOINTEGRATION" 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 LOSS OF OSSEOINTEGRATION IS INCONCLUSIVE AND SPECIFIC TO EACH CASE, PROBABLE CAUSES COULD BE THE LOSS OF PRIMARY STABILITY AT THE OSTEOTOMY SITE 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 3027904 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 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 3027904 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." 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 BRUXISM. IFU 3027904 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." THIS IS THE 2ND OF 2 FAILED IMPLANTS REPORTED ON THE SAME PATIENT. REFERENCE THE FOLLOWING MANUFACTURER REPORTS FOR THE REMAINING IMPLANTS. 3011649314-2022-00042.

    Additional Manufacturer Narrative · 0

    CAPA 23-006. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    G3: IN THE INITIAL REPORT WAS REPORTED AS 02/14/2022, HOWEVER, THE CORRECT DATE IS 02/03/2022. CAPA CA-00016 MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT LOSS INTEGRATION. THE PATIENT HAS BONE TYPE IV AND A HISTORY OF BRUXISM. THE PATIENT PRESENTED ON (B)(6) 2021 FOR PRIMARY PROCEDURE ON TOOTH #13. THE PATIENT RETURNED ON (B)(6) 2021 BEFORE THE SECOND STAGE SURGERY WITH COMPLAINTS OF PAIN. UPON EXAMINATION THE PROVIDER NOTES SIGNS OF INFECTION AND INFLAMMATION. IT WAS AT THAT TIME THE DEVICE WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT HAS BONE TYPE IV, ORAL HYGIENE REPORTED AS POOR AND A HISTORY OF BRUXISM. THE PATIENT PRESENTED ON (B)(6) 2021 FOR PRIMARY PROCEDURE ON TOOTH #13. THE PATIENT RETURNED ON (B)(6) 2021 BEFORE THE SECOND STAGE SURGERY WITH COMPLAINTS OF PAIN. UPON EXAMINATION THE PROVIDER NOTES SIGNS OF INFECTION AND INFLAMMATION. THE IMPLANT LOSS OSSEOINTEGRATION AND THE DEVICE WAS REMOVED AND REPLACED WITH A SIMILAR PRODUCT. THE SYMPTOMS RESOLVED AFTER IMPLANT REMOVAL. THERE WAS NO PERMANENT INJURY TO THE PATIENT AND NO ADDITIONAL MEDICAL/SURGICAL PROCEDURE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705798 HAHN TAPERED IMPLANT Ø4.3 X 10MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0010 6080437

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention