BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAHN TAPERED IMPLANT 4.3 X 8 MM

    MDR report key: 10686032 · Received October 15, 2020

    Report

    Report Number
    3011649314-2020-00676
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 28, 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
    FL, 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 AN 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 WITH ONLY THE THREADS BEING SLIGHTLY WORN. 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#: 6052538 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. ADDITIONALLY, THE DOCTOR NOTED THAT WHILE REMOVING THE HEALING ABUTMENT THE IMPLANT CAME OUT. THIS IS CHARACTERISTIC OF OVER-TORQUEING AT INITIAL DELIVERY OF THE IMPLANT. EXCESSIVE INSERTION TORQUE MAY RESULT IN IMPLANT FRACTURE, OR FRACTURE OR NECROSIS OF THE IMPLANT SITE WHICH MAY LEAD CAUSE A FAILURE TO OSSEOINTEGRATE. "FAILURE TO OSSEOINTEGRATE" 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 FAILURE TO OSSEOINTEGRATE IS INCONCLUSIVE AND SPECIFIC TO EACH CASE, 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. PREMATURE LOADING, PATIENT'S HEALTH, PERI-IMPLANTITIS, SMOKING, AND LACK OF ORAL HYGIENE MAY ALSO BE CONTRIBUTING FACTORS. IFU 3027904 REV 2.0 (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." 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 Manufacturer Narrative · 1

    THE PATIENT'S WEIGHT WAS NOT RECORDED BY THE CUSTOMER. 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 PLACED ON (B)(6) 2020 AT TOOTH LOCATION #18. THE PATIENT RETURNED ON (B)(6) 2020 FOR A FOLLOW-UP VISIT, AND PRESENTED WITH NO SYMPTOMS. AS THE DOCTOR WAS REMOVING THE HEALING ABUTMENT, THE IMPLANT CAME OUT ALONG WITH THE ABUTMENT. THE NOTED THAT THE IMPLANT HAD FAILED TO OSSEOINTEGRATE. THE PATIENT IS CURRENTLY REPORTED TO BE IN EXCELLENT CONDITION. THE PATIENT HAS TYPE III BONE QUALITY, AND HAS NO RELEVANT MEDICAL OR DENTAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149807 HAHN TAPERED IMPLANT 4.3 X 8 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0009 6052538

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR