BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.7 MMD X 10 MML X 3.5 MMP

    MDR report key: 9079874 · Received September 17, 2019

    Report

    Report Number
    3011649314-2019-00532
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    June 15, 2019
    Report Date
    December 18, 2019
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: RETURNED SAMPLE: THE IMPLANT WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE PART WAS MEASURED AND VERIFIED TO BE AN INCLUSIVE TAPERED IMPLANT 3.7 MM X 10 MM X 3.5 MM (70-1070-IMP0006). COMPLAINT INVESTIGATOR MEASURED THE CRITICAL PARAMETERS AGAINST DWG 3003651 REV 6.0 FROM DHR AND FOUND NO DEVIATION. THE IMPLANT THREAD WAS INTACT. THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED. NO BONE DEBRIS WAS OBSERVED FROM THE IMPLANT. 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. ROOT CAUSE: "LOSS OF 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. 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 TO THE LACK OF OSSEOINTEGRATION. IFU 3023579 REV 3.0 (INCLUSIVE DENTAL IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN CONTRAINDICATIONS SECTION: "INCLUSIVE DENTAL IMPLANTS SHOULD NOT BE PLACED IN PATIENTS DISCOVERED TO BE MEDICALLY UNFIT FOR THE INTENDED TREATMENT. PRIOR TO CLINICAL INTERVENTION, PROSPECTIVE PATIENTS MUST BE THOROUGHLY EVALUATED FOR ALL KNOWN RISK FACTORS AND CONDITIONS RELATED TO ORAL SURGICAL PROCEDURES AND SUBSEQUENT HEALING. CONTRAINDICATIONS INCLUDE BUT ARE NOT LIMITED TO: UNCONTROLLED PARAFUNCTIONAL HABITS..." IN THIS CASE, THE PATIENT WAS REPORTED HAVING BRUXISM AS A PARAFUNCTIONAL ACTIVITY. 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." 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 WIL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCLUSIVE TAPERED IMPLANT FAILED. THE DOCTOR REPORTED THAT THE IMPLANT WAS PLACED ON (B)(6) 2016 AT TOOTH LOCATION #11. THE PATIENT RETURNED ON (B)(6) 2019 COMPLAINING OF PAIN. UPON EXAMINATION, THE DOCTOR NOTED THAT THERE WAS SWELLING AT THE IMPLANT SITE, BUT NO INFECTION WAS REPORTED. THE IMPLANT WAS THEN REMOVED DUE TO LOSS OF OSSEOINTEGRATION. THE PATIENT'S CURRENT STATUS IS REPORTED TO BE GOOD. THE PATIENT HAS TYPE I BONE QUALITY, AND HAS A HISTORY OF PARAFUNCTION/BRUXISM. THERE WERE NO ABNORMALITIES NOTED WITH THE IMPLANT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872258 INCLUSIVE TAPERED IMPLANT 3.7 MMD X 10 MML X 3.5 MMP INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0006 6008962

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention