BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT 3.5 X 11.5 MM

    MDR report key: 9772374 · Received February 28, 2020

    Report

    Report Number
    3011649314-2020-00465
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    August 8, 2019
    Report Date
    November 24, 2020
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: INVESTIGATION METHODS/RESULTS: CUSTOMER DID NOT RETURN THE IMPLANT FOR INVESTIGATION. DEVICE HISTORY RECORD: THE DHR WAS REVIEWED 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 REVIEW: THERE WAS NO STOCK PRODUCT FROM LOT# 6052527 AVAILABLE FOR REVIEW. ROOT CAUSE: PER THE REPORTED INFORMATION, THE PATIENT HAD TYPE III BONE QUALITY. IT HAS BEEN SHOWN THAT THE QUALITY AND QUANTITY OF BONE AVAILABLE AT THE IMPLANT SITE ARE VERY IMPORTANT PATIENT FACTORS, IN DETERMINING THE SUCCESS OF DENTAL IMPLANTS. IT IS DIFFICULT TO OBTAIN IMPLANT ANCHORAGE IN BONE THAT IS NOT VERY DENSE. TYPE III: THIN LAYER OF CORTICAL BONE SURROUNDING A CORE OF DENSE TRABECULAR BONE. THEREFORE, THE PATIENT'S BONE QUALITY MAY HAVE BEEN A FACTOR IN THE FAILED OSSEOINTEGRATION OF THE IMPLANT. 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. IFU 3034554 REV 1.0 (HAHN TAPERED IMPLANT SYSTEM INSTRUCTION FOR USE) CONTAINS THE FOLLOWING STATEMENT IN IMPLANT PLACEMENT SECTION: "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." THE IFU ALSO 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 PRECAUTION SECTION: "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."

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. WHEN/IF THE DEVICE IS RETURNED FOR EVALUATION, THE NEW INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAHN TAPERED IMPLANT FAILED. THE DOCTOR REPORTED THAT THE IMPLANT WAS PLACED ON (B)(6) 2019 AT TOOTH LOCATION #23. THE PATIENT RETURNED ON (B)(6) 2019 COMPLAINING OF PAIN AND SWELLING. AFTER EXAMINATION, THE DOCTOR NOTED THAT THE IMPLANT LACKED PRIMARY STABILITY. IT WAS AT THAT TIME THAT THE IMPLANT WAS REMOVED. THE PATIENT IS CURRENTLY REPORTED TO HAVE HEALED, AND A NEW IMPLANT WAS PLACED ON (B)(6) 2019. THE PATIENT HAS TYPE III BONE QUALITY. THE PATIENT ALSO HAS A HISTORY OF DIABETES, HIGH CHOLESTEROL, HIGH BLOOD PRESSURE, AND TAKES BLOOD THINNER ELIQUIS. THERE WAS NO ABNORMALITY NOTED WITH THE IMPLANT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234420 HAHN TAPERED IMPLANT 3.5 X 11.5 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0006 6052527

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention