BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE MINI IMPLANT O-BALL 2.2 MMD X 13 MML

    MDR report key: 18746721 · Received February 21, 2024

    Report

    Report Number
    3011649314-2024-00130
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    December 27, 2023
    Report Date
    March 25, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K100932
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS HOWEVER, THE EVALUATION OF THE DEVICE IS PENDING. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT#: 6100884 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 REVIEWED RESULTS: THE STOCK PRODUCT FOR LOT#: 6100884 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE AN INCLUSIVE MINI IMPLANT O-BALL 2.2 MMD X 13 MML (70-1068-IMP0002) USING RADIOGRAPHIC TEMPLATE (GD-455-0512). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. MATTER WAS OBSERVED IN THE THREADING OF THE IMPLANT. THE COMPLAINT IS VERIFIED BASED ON THE RETURNED PART BUT CANNOT CONFIRM THE FAILURE MODE. THERE WAS NO EVIDENCE FOUND THAT INDICATED THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF. ROOT CAUSE: "FAILURE TO OSSEOINTEGRATE" IS A COMMON COMPLAINT IN REGARD 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 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 4990 REV 3.0 (INCLUSIVE MINI IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE CONTRAINDICATIONS SECTION: "PATIENTS SHOULD BE EVALUATED BEFORE THE TIME OF SURGERY FOR FACTORS THAT PUT THEM AT RISK FROM THE IMPLANT PLACEMENT PROCEDURE, OR THAT MAY AFFECT HEALING OF BONE OR SURROUNDING SOFT TISSUE. IMPLANT PLACEMENT IN PATIENTS MEDICALLY UNFIT FOR ORAL SURGICAL PROCEDURES IS CONTRAINDICATED. PATIENTS WITH SYSTEMIC, LOCALIZED OR PHARMACEUTICAL TREATMENT FACTORS THAT COMPROMISE THEIR ABILITY TO HEAL SHOULD BE CAREFULLY EVALUATED. DO NOT PLACE INCLUSIVE MINI IMPLANTS IF THERE IS NOT ADEQUATE BONE WIDTH OR HEIGHT TO CONTAIN THE IMPLANT." IFU 4990 REV 3.0 (INCLUSIVE MINI IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE 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. FOR BEST RESULTS, PLEASE OBSERVE THE FOLLOWING PRECAUTIONS: ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL, 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." IFU 4990 REV 3.0 (INCLUSIVE MINI IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE WARNINGS 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." IFU 4990 REV 3.0 (INCLUSIVE MINI IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE WARNINGS SECTION: "INCLUSIVE MINI IMPLANTS SHOULD ALWAYS BE USED IN SUFFICIENT QUANTITY TO PREVENT EXCESSIVE STRESS ON THE IMPLANTS; AT LEAST ONE PAIR IN ALL CASES. 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." IFU 4990 REV 3.0 (INCLUSIVE MINI IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE FINAL INSERTION SECTION: " NOTE: IF THE IMPLANT CANNOT BE FULLY SEATED USING THE RECOMMENDED TORQUE, IT MAY BE NECESSARY TO REVERSE THE IMPLANT FROM THE SITE AND DRILL AGAIN TO INCREASE THE DEPTH OF THE OSTEOTOMY. FOR POSITIVE LONG-TERM PROGNOSIS, SOLID RESISTANCE MUST BE MET DURING FINAL INSERTION. INADEQUATE RESISTANCE CONTRAINDICATES PRIMARY STABILITY AND LOADING." THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). CAPA: 24-005.

    Additional Manufacturer Narrative · 0

    CORRECTION: C (SUSPECT PRODUCT): IN THE PREVIOUS REPORT, IT WAS INADVERTENTLY LEFT BLANK. THEREFORE, G4 WAS REPORTED AS A COMBINATION PRODUCT. CAPA 24-005 AND CAPA CA-00016. THE MANUFACTURER'S INTERNAL REFERENCE NUMBER IS (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE INCLUSIVE MINI IMPLANT FAILED TO OSSEOINTEGRATE ON TOOTH #10. NO MEDICAL HISTORY REPORTED. THE PATIENT'S BONE QUALITY IS TYPE II AND THE PATIENT'S ORAL HYGIENE STATUS IS GOOD. THE PATIENT RETURNED BEFORE THE SECOND STAGE SURGERY WITH COMPLAINTS OF PAIN. UPON EXAMINATION THE PROVIDER NOTICED INFLAMMATION. THE DEVICE WAS REMOVED AND NOT REPLACED. PATIENT'S SYMPTOMS RESOLVED AFTER IMPLANT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445110 INCLUSIVE MINI IMPLANT O-BALL 2.2 MMD X 13 MML INCLUSIVE MINI IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1068-IMP0002 6100884

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention