BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE MINI IMPLANT O-BALL 2.5 MMD X 10 MML

    MDR report key: 9293990 · Received November 7, 2019

    Report

    Report Number
    3011649314-2017-00527
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    September 15, 2017
    Report Date
    November 7, 2019
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K100932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S RACE AND ETHNICITY WERE NOT PROVIDED. THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: 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. RETURNED SAMPLE: THE IMPLANT WAS RETURNED BUT NOT IN THE ORIGINAL PACKAGE. THE PART WAS MEASURED AND VERIFIED TO BE AN INCLUSIVE MINI IMPLANT O-BALL 2.5 MMD X 10 MML (70-1068-IMP0004). COMPLAINT INVESTIGATOR MEASURED THE CRITICAL PARAMETERS AGAINST DWG 3002389 REV 4.0 FROM DHR AND FOUND NO DEVIATION. THE RETURNED IMPLANT HAD NO DEFECT OR NON-CONFORMITY. THE THREADS AND THE O-BALL WERE INTACT. BONE DEBRIS WAS OBSERVED. ROOT CAUSE: 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. PER OBTAINED INFORMATION, CUSTOMER REPORTED HE TOOK TIME TO DRILL AND POSSIBLY WIDEN THE DRILL SPACE SO PRIMARY STABILITY WAS NOT GOOD. 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." IFU3023579 REV 3.0 (INCLUSIVE DENTAL IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN DRILLING PROTOCOL, "SELECT THE APPROPRIATE CORTICAL BONE DRILL, AS DETERMINED BY THE PATIENT'S BONE DENSITY AND THE DIAMETER OF THE IMPLANT TO BE PLACED. CAREFULLY PLACE THE DRILL DIRECTLY ABOVE THE IMPLANT SITE AND GENTLY DRILL THROUGH THE TISSUE AND ALVEOLAR CREST USING AN IN-AND-OUT MOTION AND PROFUSE, STERILE IRRIGATION TO A DEPTH OF ONE-THIRD TO ONE-HALF THE LENGTH OF THE IMPLANT THREADS. IF PLACING 3.0 MM DIAMETER INCLUSIVE MINI IMPLANTS, CONTINUE DRILLING TO A DEPTH OF AT LEAST TWO-THIRDS THE LENGTH OF THE IMPLANT THREADS." THE CUSTOMER REPORTED HE CANNOT ADVANCE THE IMPLANT AND PENETRATE WELL TO ENGAGE ALVEOLAR BONE AFTER CORTICAL BONE DRILL 2/3. IT WAS UNKNOWN IF THE CUSTOMER OVER-PREPARE THE OSTEOTOMY SITE WHEN PLACING 2.5 MM DIAMETER INCLUSIVE MINI IMPLANTS. IFU 3023579 REV 3.0 (INCLUSIVE DENTAL IMPLANT SYSTEM) 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." THE PATIENT WAS REPORTED TO HAVE AN OCCLUSAL TRAUMA. THIS IS THE FIRST OF THREE IMPLANT COMPLAINTS, SEE MANUFACTURER REPORT FOR THE REMAINING COMPLAINT : 3011649314-2017-00528 (B)(4), 3011649314-2017-00529 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INCLUSIVE MINI IMPLANT FAILED. THE PATIENT BONE GRADE IS NOTED AS GRADE III. THE PATIENT HAS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT. THE PATIENT PRESENTED ON (B)(6) 2017 FOR IMPLANT PLACEMENT ON TOOTH #22, 23, 26 AND 27. THE IMPLANT PLACED ON #23 DID NOT OBTAIN STABILITY AND WAS REMOVED THE SAME DAY. THE PROVIDER REPORTED THAT "IT WAS TOO DIFFICULT TO ADVANCE MINI-IMPLANT AFTER CORTICAL BONE DRILL, LACK OF BONE STABILITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086659 INCLUSIVE MINI IMPLANT O-BALL 2.5 MMD X 10 MML INCLUSIVE MINI IMPLANT O-BALL DZE PRISMATIK DENTALCRAFT, INC. 70-1068-IMP0004 6045198

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR