INCLUSIVE MINI IMPLANT O-BALL 3.0 MMD X 10 MML
Report
- Report Number
- 3011649314-2023-00711
- Event Type
- Injury
- Date Received
- November 20, 2023
- Date of Event
- October 17, 2023
- Report Date
- September 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
- NJ, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS THE DHR WAS REVIEWED FOR INCLUSIVE MINI IMPLANT LOT# 6122854 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# 6122854 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 3.0 MMD X 10 MML ((B)(4)) USING RADIOGRAPHIC TEMPLATE ((B)(4)). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. 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" AND "FAILURE TO OSSEOINTEGRATE" ARE BOTH COMMON COMPLAINTS IN REGARD TO IMPLANT FAILURE. THESE OCCUR WHEN THE PATIENT'S BONE DOES NOT INTEGRATE WITH THE IMPLANT SURFACE. THE POSSIBLE RESPONSES TO THESE COMPLAINTS COULD BE ATTRIBUTED TO VARIOUS CAUSES. ALTHOUGH THE ROOT CAUSE FOR LACK OF PRIMARY STABILITY AND FAILURE TO OSSEOINTEGRATE ARE BOTH 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'S ORAL HYGIENE IS NOTED AS FAIR. 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 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 (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 (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." CORRECTION - G4 PREMARKET IDENTIFICATION PMA/510(K), H4 DEVICE MANUFACTURE DATE.
THE DEVICE HAS NOT BEEN RETURNED. ONCE THE DEVICE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
ADDITIONAL INFORMATION: B1, B2, H6. CORRECTED INFORMATION: B5, D4, G1, H1. CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).
THE DEVICE INVESTIGATION HAS BEEN UPDATED AND THE RESULTS ARE AS FOLLOWS: STOCK PRODUCT REVIEWED RESULTS: A REVIEW OF STOCK PRODUCT WAS PERFORMED FOR INCLUSIVE MINI IMPLANT LOT# 6122854 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. PER THE REPORTED INFORMATION, THERE WAS AN IMPLANT FIT ISSUE. THE PROBABLE CAUSE FOR THE FIT ISSUE MAY BE DUE TO AN OVER PREPARED OSTEOTOMY. IFU-4990 REV 4 (INCLUSIVE MINI IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN DRILLING PROTOCOL SECTION: "IF PLACING 3.0 MM DIAMETER INCLUSIVE MINI IMPLANTS, CONTINUE DRILLING TO A DEPTH OF AT LEAST TWO-THIRDS (2/3) THE LENGTH OF THE IMPLANT THREADS. FOR THE MAJORITY OF IMPLANT SITES, THIS IS THE EXTENT OF THE DRILLING THAT IS REQUIRED. HOWEVER, IN DENSE BONE, THE DRILLING DEPTH MAY NEED TO BE GREATER. THE GOAL IS TO ACHIEVE HIGH PRIMARY STABILITY WITH AN INSERTION TORQUE OF APPROXIMATELY 35 NCM, TAKING CARE NOT TO EXCEED THE RECOMMENDED MAXIMUM OF 45 NCM." PER THE REPORTED INFORMATION, THERE WAS A BUCCAL PLATE FRACTURE AS WELL. THE PROBABLE CAUSE FOR THE BUCCAL PLATE FRACTURE MAY BE DUE TO THE OVER TORQUING OF THE IMPLANT. IFU-4990 REV 4 (INCLUSIVE MINI IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN FINAL INSERTION SECTION: "OPTIMAL FINAL INSERTION OF THE IMPLANT LEAVES THE IMPLANT HEAD FULLY EXPOSED, WHILE THE COLLAR IS EMBEDDED IN THE GINGIVA WITH NO THREADS VISIBLE. FOR IMMEDIATE LOADING OF THE IMPLANT, FINAL TORQUE AT SEATING SHOULD BE 30-35 NCM MINIMUM. EXCEEDING 45 NCM TORQUE DURING IMPLANT PLACEMENT IS NOT RECOMMENDED." CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).
CORRECTION: H11. CAPA CA-00016 WAS ADDED ERRONEOUSLY IN THE PREVIOUS FOLLOW UP REPORT 3011649314-2023-00711-3 AND IS NOT APPLICABLE. MANUFACTURER REFERENCE: (B)(4).
IT WAS REPORTED THAT THE INCLUSIVE MINI IMPLANT FAILED DUE TO LACK OF PRIMARY STABILITY BECAUSE THE BUCCAL PLATE FRACTURED DURING PLACEMENT. THE PATIENT PRESENTED WITH THE ISSUE ON (B)(6). 2023 FOR A PRIMARY PROCEDURE ON TOOTH #27. THE IMPLANT WAS PLACED ON (B)(6). 2023 AND EXPLANTED THE SAME DAY ON (B)(6). 2023. PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. THE IMPLANT WAS REPLACED. PATIENT'S BONE QUALITY IS TYPE III AND HAS FAIR ORAL HYGIENE.
IT WAS REPORTED THAT THE INCLUSIVE MINI IMPLANT FAILED. THE PATIENT PRESENTED ON (B)(6) 2023 FOR IMPLANT PLACEMENT ON TOOTH #27. PATIENT'S BONE QUALITY WAS REPORTED AS TYPE III AND THE ORAL HYGIENE AS FAIR. THE PROVIDER REPORTED THAT BUCCAL PLATE FRACTURED DURING IMPLANT PLACEMENT AND THERE WAS A LACK OF PRIMARY STABILITY / FAILURE TO OSSEOINTEGRATE. PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, THERE WAS NO PERMANENT PATIENT INJURY AND THE IMPLANT WAS NOT REPLACED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL/SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1797237 | INCLUSIVE MINI IMPLANT O-BALL 3.0 MMD X 10 MML | INCLUSIVE IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1068-IMP0007 | 6122854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Required Intervention |