BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE MINI IMPLANT O-BALL 2.2MMD X 10MML

    MDR report key: 15269565 · Received August 22, 2022

    Report

    Report Number
    3011649314-2022-00473
    Event Type
    Injury
    Date Received
    August 22, 2022
    Date of Event
    July 18, 2022
    Report Date
    July 29, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K100932
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS INFORMATION NOT PROVIDED WHEN ASKED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. HOWEVER, THE NON-VISUAL DEVICE EVALUATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT# 6092134 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. THERE WAS NO STOCK PRODUCT FROM LOT# 6092134 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS: CUSTOMER HAS NOT RETURNED THE COMPLAINT PART FOR INVESTIGATION TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. 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. IFU-4989 REV 4.0 (INCLUSIVE TAPERED IMPLANTS) 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." IFU-4989 REV 4.0 (INCLUSIVE TAPERED IMPLANTS) CONTAINS THE FOLLOWING STATEMENT IN WARNING 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. IN ADDITION, IFU-4989 REV 4.0 (INCLUSIVE TAPERED IMPLANTS) 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. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: D4, H6 (TYPE OF INVESTIGATION CODES). CORRECTED DATA: B5, G3, H3, H6 (HEALTH EFFECT - IMPACT CODE, AND MEDICAL DEVICE PROBLEM CODE). NOTE: G3 IN THE INITIAL REPORT WAS REPORTED AS (07-29-2022), HOWEVER, THE CORRECT DATE IS (07-20-2022). CAPA: 23-006. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE BONE GRADE IS NOTED AS GRADE III. THE PATIENT HAS A MEDICAL HISTORY OF ARTHRITIS AND LIVER DISEASE. THERE IS NO DENTAL HISTORY PRIOR TO IMPLANT. THE PATIENT PRESENTED ON (B)(6) 2022 FOR IMPLANT PLACEMENT ON TOOTH #26. THE PATIENT RETURNED ON (B)(6) 2022 WITH COMPLAINTS OF PAIN. UPON EXAM THE PROVIDER NOTES A FAILURE OF INTEGRATION AND A GENERAL BONE LOSS. HOWEVER, BASED ON THE DATES PROVIDED, IT IS DETERMINED THAT THE DEVICE LACKED STABILITY AND THE DEVICE WAS REMOVED. IT WAS AT THAT TIME THE DEVICE WAS REMOVED. THE PATIENT CURRENT STATUS IS NOTED AS "SATISFACTORY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE BONE GRADE IS NOTED AS GRADE III. THE PATIENT HAS A MEDICAL HISTORY OF ARTHRITIS AND LIVER DISEASE. THERE IS NO DENTAL HISTORY PRIOR TO IMPLANT. THE PATIENT PRESENTED ON (B)(6) 2022 FOR IMPLANT PLACEMENT ON TOOTH #26. THE PATIENT RETURNED ON (B)(6) 2022 WITH COMPLAINTS OF PAIN. UPON EXAMINATION THE PROVIDER NOTED A GENERAL BONE LOSS AND THE IMPLANT FAILED TO INTEGRATE, AND THE DEVICE WAS REMOVED. THE PATIENT CURRENT STATUS IS NOTED AS "SATISFACTORY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2492857 INCLUSIVE MINI IMPLANT O-BALL 2.2MMD X 10MML INCLUSIVE MINI IMPLANT O-BALL DZE PRISMATIK DENTALCRAFT, INC. 70-1068-IMP0001 6105605

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention