BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE MINI IMPLANT O-BALL 2.5 MMD X 13 MML

    MDR report key: 17484128 · Received August 8, 2023

    Report

    Report Number
    3011649314-2023-00514
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    June 15, 2023
    Report Date
    May 22, 2025
    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, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS THE DHR WAS REVIEWED FOR LOT# 6123402 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 INCLUSIVE MINI IMPLANT LOT# 6123402 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED. INVESTIGATION METHODS/RESULTS THE DEVICE WAS RETURNED BUT NOT IN THE ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE AN INCLUSIVE MINI IMPLANT 2.5 MMD X 13 MML (PART# 70-1068-IMP0005) USING RADIOGRAPHIC TEMPLATE (3007325-01). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. BONE DEBRIS WAS OBSERVED IN THE THREADING OF THE IMPLANT (SEE ATTACHED IMAGES). 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 "LACK OF PRIMARY STABILITY" 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 LACK OF PRIMARY STABILITY 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. PER THE REPORTED INFORMATION PATIENT HAS A HISTORY OF SMOKING. IFU-4990 REV 4.0 (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 4.0 (INCLUSIVE MINI IMPLANT SYSTEM) 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." IFU-4990 REV 4.0 (INCLUSIVE MINI 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." IFU-4990 REV 4.0 (INCLUSIVE MINI IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN 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. · PRIOR TO SURGERY, ENSURE THAT THE NEEDED COMPONENTS, INSTRUMENTS AND ANCILLARY MATERIALS ARE COMPLETE, FUNCTIONAL AND AVAILABLE IN THE CORRECT QUANTITIES." THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. IF/ WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES. SECTION A A4: PATIENT'S WEIGHT IS NOT RECORDED AT THE TIME OF THE OFFICE VISIT. A5: PATIENT'S RACE IS NOT RECORDED AT THE TIME OF THE OFFICE VISIT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: B1, B2, H6 (MEDICAL DEVICE PROBLEM CODE - 2933, TYPE OF INVESTIGATION CODES, AND INVESTIGATION CONCLUSIONS CODE). CORRECTED DATA: B5, D9, E1, G1, G4, H1, H6 (HEALTH EFFECT - IMPACT CODE, AND MEDICAL DEVICE PROBLEM CODE-1863). CAPA: CA-00016. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INCLUSIVE MINI IMPLANT O-BALL FAILED. THE PATIENT'S BONE TYPE IS I, AND THEIR ORAL HYGIENE IS NOTED AS GOOD. THE PATIENT HAS A HISTORY OF SMOKING. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #27. THE PATIENT RETURNED ON (B)(6) 2023 WITH THE IMPLANT IN HAND. THE PROVIDER DETERMINED THAT THE IMPLANT FAILED TO INTEGRATE. BASED ON THE DATES NOTED IN THE QUESTIONNAIRE COMPLETED BY THE PROVIDER, A MEDICAL OPINION WAS SOUGHT, AND IT WAS DETERMINED THAT BECAUSE THE IMPLANT WAS PLACED AND REMOVED IN SUCH A SHORT TIME, IT LACKED STABILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INCLUSIVE MINI IMPLANT O-BALL FAILED. THE PATIENT'S BONE TYPE IS I, AND THEIR ORAL HYGIENE IS NOTED AS GOOD. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #27. THE PATIENT RETURNED ON (B)(6) 2023 WITH THE IMPLANT IN HAND. THE PROVIDER DETERMINED THAT THE IMPLANT FAILED TO INTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657666 INCLUSIVE MINI IMPLANT O-BALL 2.5 MMD X 13 MML INCLUSIVE MINI IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1068-IMP0005 6123402

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention