BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE TAPERED IMPLANT 4.2 MMD X 10 MML X 3.5 MMP

    MDR report key: 9777473 · Received March 2, 2020

    Report

    Report Number
    3011649314-2020-00496
    Event Type
    Injury
    Date Received
    March 2, 2020
    Date of Event
    February 18, 2020
    Report Date
    June 29, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED AND INDICATE THE PART MET ALL THE CRITERIA CALLED FOR IN THE PRODUCTION ROUTER. STOCK PRODUCT REVIEWED RESULTS THERE WAS NO STOCK FROM LOT# 6017393 AVAILABLE FOR INVESTIGATION. INVESTIGATION METHODS/RESULTS INVESTIGATOR REVIEWED THE DRAWING 3031815 FROM DHR AND CONFIRMED THE RETURNED DEVICE WAS NOT INCLUSIVE TAPERED IMPLANT 4.2 MMD X 10 MML X 3.5 MMP. SME ALSO CONFIRMED THE RETURNED IMPLANT SHARE NO FEATURES WITH INCLUSIVE IMPLANT, MEANING THE CUSTOMER DID NOT RETURN THE REPORTED IMPLANTS FOR INVESTIGATION. ROOT CAUSE "FAIL OSSEOINTEGRATION" 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 MENTIONED BELOW. ALTHOUGH THE ROOT CAUSE FOR LOST OSSEOINTEGRATION 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 TO THE LACK OF OSSEOINTEGRATION. 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." 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." 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED. AN INVESTIGATION WILL BE CONDUCTED ONCE THE SAMPLE HAS BEEN RETURNED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE OF BIRTH - ASKED, BUT UNKNOWN. UDI HAD NOT BEEN IMPLEMENTED FOR CLASS II DEVICES IN 2015. THIS IS THE SECOND OF THREE IMPLANTS, PLEASE SEE MANUFACTURER NUMBERS 3011649314-2020-00494 & 3011649314-2020-00497 FOR THE FIRST AND THIRD IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCLUSIVE TAPERED IMPLANT 4.2 MMD X 10 MML X 3.5 MMP FAILED TO OSSEOINTEGRATE. THERE WAS NO PAIN; HOWEVER, THE IMPLANT SITE WAS INFECTED. THE IMPLANT WAS PLACED INTO TOOTH # 13 ON (B)(6) 2020 AND WAS EXPLANTED ON (B)(6) 2020. THE IMPLANT SITE HAS TYPE III BONE QUALITY. THE PATIENT HAS NO RELEVANT MEDICAL OR DENTAL PRE-EXISTING CONDITION. THE PATIENT WAS REPORTED TO BE FINE. THERE WAS NO ABNORMALITY OBSERVED WITH THE IMPLANT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238776 INCLUSIVE TAPERED IMPLANT 4.2 MMD X 10 MML X 3.5 MMP INCLUSIVE TAPERED IMPLANT 4.2 MMD X 10 MML X 3.5 MMP DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0027 6017393

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention