BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAHN TAPERED IMPLANT 4.3 X 8 MM

    MDR report key: 10715016 · Received October 21, 2020

    Report

    Report Number
    3011649314-2020-00683
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    August 6, 2020
    Report Date
    May 18, 2021
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø4.3 X 8 MM (70-1154-IMP0009) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. SIGNIFICANT BONE DEBRIS WAS OBSERVED IN THE THREADING OF THE IMPLANT. DEVICE HISTORY RECORD REVIEW: 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#: 6070331 AVAILABLE FOR REVIEW. ROOT CAUSE: PROBABLE CAUSES FOR LOSS OF PRIMARY STABILITY AT THE OSTEOTOMY SITE CAN 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. 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. IFU 3023579 REV 3.0 (INCLUSIVE DENTAL 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." IN ADDITION, 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 BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAHN TAPERED IMPLANT FAILED. THE IMPLANT WAS PLACE ON (B)(6) 2020 AT TOOTH LOCATION #13. AS THE IMPLANT WAS BEING PLACED, THE DOCTOR STATED THAT THE IMPLANT JUST KEPT SPINNING, AND THAT PRIMARY STABILITY COULD NOT BE ACHIEVED. THE DOCTOR IMMEDIATELY REMOVED THE IMPLANT, AND SUCCESSFULLY PLACED A LARGER SIZE IMPLANT. THE PATIENT IS CURRENTLY REPORTED TO BE IN GOOD CONDITION. THE PATIENT HAS TYPE II BONE QUALITY, AND HAS NO RELEVANT MEDICAL OR DENTAL HISTORY. THERE WAS NO ABNORMALITY NOTED WITH THE IMPLANT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179153 HAHN TAPERED IMPLANT 4.3 X 8 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0009 6070331

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR