BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø3.5 X 13 MM

    MDR report key: 15349489 · Received September 2, 2022

    Report

    Report Number
    3011649314-2022-00490
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    January 4, 2022
    Report Date
    July 23, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT# 6113529 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 Ø3.5 X 13 MM (70-1154-IMP0007) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. 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. PREMATURE LOADING, PATIENT'S HEALTH, PERI-IMPLANTITIS, SMOKING, AND LACK OF ORAL HYGIENE MAY ALSO BE CONTRIBUTING FACTORS. IFU 3027904 REV 3.0 (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 3.0 (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." ADDITIONAL INFORMATION PROVIDED BY THE PROVIDER: SECTION A3: UPDATED TO REFLECT THE NEW INFORMATION PROVIDED. SECTION A4: UPDATED TO REFLECT THE NEW INFORMATION PROVIDED. SECTION A6: UPDATED TO REFLECT THE NEW INFORMATION PROVIDED. SECTION B3: UPDATED TO REFLECT THE NEW INFORMATION PROVIDED. SECTION B4: THE INITIAL DATE OF SUBMISSION IS 09-02-22. THIS INFORMATION WAS OMITTED FROM THE INITIAL SUBMISSION. SECTION B5: UPDATED TO REFLECT THE NEW INFORMATION PROVIDED. SECTION D4: EXPIRATION DATE ADDED AS IT WAS OMITTED FROM THE INITIAL SUBMISSION. SECTION D6B: UPDATED TO REFLECT THE NEW INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: B1, B2, E1, H6 CORRECTED DATA: H1. CAPA 23-006. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED 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. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #8. THE PATIENT RETURNED ON (B)(6) 2022, WITHIN THREE WEEKS OF PLACEMENT, WITHOUT COMPLAINT. UPON EXAMINATION, THE PROVIDER NOTED THAT AFTER THE IMPLANT WAS PLACED, WE NOTICED IT "DRIFT" AND LOST PRIMARY STABILITY, AND THE DEVICE WAS REMOVED.

    Description of Event or Problem · 0

    DURING THE EXAM ON (B)(6) 2021, THE DOCTOR NOTED THE IMPLANT WAS STABLE AND SHOWED NO SIGNS OF INFECTION. THE PATIENT RETURNED ON (B)(6) 2022 AT WHICH TIME THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134683 HAHN TAPERED IMPLANT Ø3.5 X 13 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0007 6113529

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention