BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE MINI IMPLANT O-BALL 2.5 MMD X 10 MML

    MDR report key: 20610940 · Received November 5, 2024

    Report

    Report Number
    3011649314-2024-00852
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    September 27, 2024
    Report Date
    April 10, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K100932
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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). THIS IS THE FIRST OF TWO COMPLAINTS FOR THE SAME PATIENT, RELATED MDR NUMBER: 3011649314-2024-00855.

    Additional Manufacturer Narrative · 0

    THE DEVICE ANALYZED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR INCLUSIVE MINI IMPLANT O-BALL LOT# 6122855 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: A REVIEW OF STOCK PRODUCT WAS PERFORMED FOR INCLUSIVE MINI IMPLANT O-BALL LOT# 6122855 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE SIZE OF THE RETURNED PRODUCT DID NOT MATCH THE SIZE OF THE REPORTED PRODUCT. THE IMPLANT WAS VERIFIED TO BE AN INCLUSIVE MINI IMPLANT O-BALL 2.2 MMD X 13 MML USING RADIOGRAPHIC TEMPLATE (GD-455-0512). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. 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 4 (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 4 (INCLUSIVE MINI IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE SURGICAL PROCEDURES UNDER THE 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. 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 4 (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 4 (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." CORRECTION: A2. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT AN INCLUSIVE MINI IMPLANT O-BALL FAILED. THE PATIENT'S BONE QUALITY IS TYPE I AND THE PATIENT'S ORAL HYGIENE IS REPORTED AS EXCELLENT. THE PATIENT PRESENTED ON (B)(6) 24 FOR A PRIMARY PROCEDURE ON TOOTH #21. THE PATIENT RETURNED ON (B)(6) 2024 WITHIN THREE WEEKS OF IMPLANT PLACEMENT WITH COMPLAINT OF PAIN. UPON EXAMINATION THE PROVIDER NOTICED THE IMPLANT FAILED TO OSSEOINTEGRATE DUE TO FITTING ISSUE. THE IMPLANT WAS REMOVED AND REPLACED. IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS RESOLVED AFTER IMPLANT REMOVAL. PER THE REPORTED INFORMATION THERE ARE NO PREEXISTING MEDICAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625171 INCLUSIVE MINI IMPLANT O-BALL 2.5 MMD X 10 MML INCLUSIVE MINI IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1068-IMP0004 6122855

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention