BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø3.5 X 10 MM

    MDR report key: 19225993 · Received May 1, 2024

    Report

    Report Number
    3011649314-2024-00264
    Event Type
    Injury
    Date Received
    May 1, 2024
    Date of Event
    March 29, 2024
    Report Date
    May 21, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS CURRENTLY ONGOING. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. ONCE THE RETURNED DEVICE HAS BEEN EVALUATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (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# 6201827 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 STOCK PRODUCT FOR HAHN TAPERED IMPLANT LOT# 6201827 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø3.5 X 10 MM (70-1154-IMP0005) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. MATTER WAS OBSERVED IN THE TREADING OF THE IMPLANT. THE COMPLAINT IS VERIFIED BASED ON THE RETURNED PART BUT CANNOT CONFIRM THE FAILURE MODE. THERE WAS NO EVIDENCE FOUND THAT INDICATED THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF. ROOT CAUSE: A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. THE PROBABLE ROOT CAUSES FOR THIS FAILURE WERE THAT THE INCORRECT COMPONENTS WERE USED DURING THE PLACEMENT OF THE IMPLANT. ANOTHER PROBABLE CAUSE WAS THE OVER/UNDER DRILLING OF THE OSTEOTOMY DURING THE IMPLANT PLACEMENT WHERE PER THE REPORTED INFORMATION, THE PATIENT HAD PAIN DURING THE IMPLANT PLACEMENT. IFU 570 REV 3 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE SITE PREPARATION SECTION: "IF PLACING A HAHN TAPERED IMPLANT THAT IS 3.5 MM IN DIAMETER OR GREATER, SHAPING DRILLS ARE USED SEQUENTIALLY TO WIDEN THE OSTEOTOMY TO THE MATCHING DIAMETER. TO AVOID OVER-PREPARATION, WIDENING DRILL DIAMETERS SHOULD BE USED ONLY AS NEEDED, AND IN PROPER SUCCESSION. EACH SHAPING DRILL IS LENGTH-SPECIFIC, TO MATCH THE LENGTH OF THE PRESCRIBED IMPLANT. OSTEOTOMY DEPTH MAY BE INCREASED SEQUENTIALLY, BEGINNING WITH SHORTER DRILL LENGTHS, PROVIDED SUFFICIENT DEPTH IS ACHIEVED WITH THE FINAL DRILL. SELECT THE DESIRED SHAPING DRILL, ACCOUNTING FOR BONE DENSITY AND THE SIZE OF THE IMPLANT TO BE PLACED. WITH COPIOUS IRRIGATION, DRILL TO DEPTH. THE FINAL DRILL SHOULD CORRESPOND WITH THE MATCHING IMPLANT SIZE, AS CHARTED BELOW, WITH THE GOAL OF ACHIEVING HIGH PRIMARY STABILITY UPON IMPLANT PLACEMENT." MANUFACTURER'S INTERNAL REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G1, H6. CAPA: CA-00016. MANUFACTURER'S INTERNAL REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT HAS A HISTORY BRUXISM. PATIENT'S ORAL HYGIENE IS GOOD AND THEIR BONE QUALITY IS TYPE 2. ON (B)(6) 2024, THE PATIENT PRESENTED FOR A PRIMARY PROCEDURE ON TOOTH #9. DURING IMPLANT PLACEMENT THE PROVIDER DETERMINED THE IMPLANT WOULD NOT SEAT TO DEPTH, AND THE PATIENT WAS EXPERIENCING PAIN. THE PROVIDER REPLACED THE IMPLANT WITH A SIMILAR DEVICE IN THE SAME PROCEDURE. SYMPTOMS RESOLVED AFTER IMPLANT REMOVAL AND REPLACEMENT. THE PATIENT HAD NO FURTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839991 HAHN TAPERED IMPLANT Ø3.5 X 10 MM HAHN TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0005 6201827

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention