BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø5.0 X 13 MM

    MDR report key: 18511179 · Received January 15, 2024

    Report

    Report Number
    3011649314-2024-00026
    Event Type
    Injury
    Date Received
    January 15, 2024
    Date of Event
    December 18, 2023
    Report Date
    August 7, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B1, B2, B5, D9, H6. CORRECTED INFORMATION: B7, H1. AN INVESTIGATION HAS BEEN PERFORMED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR HAHN TAPERED IMPLANT LOT# 6201841 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# 6201841 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED. INVESTIGATION METHODS/RESULTS: CUSTOMER DID NOT RETURN THE REPORTED DEVICE FOR REVIEW TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE: A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. PROBABLE ROOT CAUSE IS THE OVER-TORQUING OF THE IMPLANT DURING THE INITIAL PLACEMENT WHICH MAY HAVE CAUSED A FRACTURE. ADDITIONALLY, IT IS UNCLEAR THE METHODS OF IMPLANT PLACEMENT USED DURING THE INITIAL PROCEDURE AND THE INSERTION TORQUE VALUE. IFU 570 REV 3 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE IMPLANT PLACEMENT SECTION: "STEP 3: ADVANCEMENT AND FINAL SEATING - CONTINUE THREADING THE IMPLANT INTO THE OSTEOTOMY SITE USING THE PREFERRED PLACEMENT METHOD. A MINIMUM TORQUE VALUE OF 35 NCM UPON FINAL SEATING INDICATES GOOD PRIMARY STABILITY." IFU 570 REV 3 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE PRECAUTIONS SECTION: "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." CAPA 23-006. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. SHOULD THE DEVICE BE RETURNED, AN INVESTIGATION WILL BE COMPLETED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS TYPE II AND THEIR ORAL HYGIENE IS LISTED AS GOOD. THE PATIENT HAS A HISTORY OF BRUXISM. ON (B)(6)2023, THE PATIENT PRESENTED FOR A PRIMARY PROCEDURE. DURING IMPLANT PLACEMENT, THE PROVIDER DETERMINED THE IMPLANT WAS OVER TORQUED AND THE IMPLANT HEAD WAS STRIPPED. THE IMPLANT FRACTURED AT THE TIME OF IMPLANT PLACEMENT. THE DEVICE WAS THEN REMOVED FROM THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS TYPE II AND THEIR ORAL HYGIENE IS LISTED AS GOOD. THE PATIENT HAS A HISTORY OF BRUXISM. ON (B)(6) 2023, THE PATIENT PRESENTED FOR A PRIMARY PROCEDURE. DURING IMPLANT PLACEMENT, THE PROVIDER DETERMINED THE IMPLANT WAS OVER TORQUED AND THE IMPLANT HEAD WAS STRIPPED. THE DEVICE WAS THEN REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954009 HAHN TAPERED IMPLANT Ø5.0 X 13 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0017 6201841

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention