INCLUSIVE TAPERED IMPLANT 3.7 MMD X 10 MML X 3.5 MMP
Report
- Report Number
- 3011649314-2022-00627
- Event Type
- Injury
- Date Received
- November 19, 2022
- Date of Event
- July 12, 2022
- Report Date
- June 13, 2025
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- DZE
- PMA / PMN Number
- K121406
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
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.
THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT# 6092132 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 PACKAGED STOCK PRODUCT IS NOT APPLICABLE FOR REVIEW SINCE NO DEFECT WAS OBSERVED FROM THE RETURNED PRODUCT. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE DEVICE WAS VERIFIED TO BE AN INCLUSIVE TAPERED IMPLANT 3.7 MMD X 10 MML X 3.5 MMP (70-1070-IMP0006) USING RADIOGRAPHIC TEMPLATE ((B)(4)). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. MINIMAL BONE DEBRIS WAS OBSERVED ON THE IMPLANT. ROOT CAUSE: "LACK OF PRIMARY STABILITY" 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 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. IFU 3023579 REV 4.0 (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." IN ADDITION. IFU 3023579 REV 4.0 (INCLUSIVE DENTAL 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. ALSO, IFU 3023579 REV 4.0 (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. 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 IS THE 1ST OF 2 FAILED IMPLANTS REPORTED ON THE SAME PATIENT. REFERENCE THE FOLLOWING MANUFACTURER REPORTS FOR THE REMAINING IMPLANTS. 3011649314-2022-00628. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES.
CAPA 23-006. MANUFACTURER REFERENCE: (B)(4).
. NOTE: IN PREVIOUS REPORTS B3 AND D6B WERE REPORTED IN ERROR BECAUSE IT IS UNCONFIRMED WHEN THE IMPLANT WAS REMOVED. CAPA CA-00016 MANUFACTURER REFERENCE: (B)(4).
IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS IV, AND THEIR ORAL HYGIENE IS LISTED AS FAIR. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #11. DURING PLACEMENT OF THE DEVICE, THE PROVIDER WAS UNABLE TO ACHIEVE PRIMARY STABILITY. IT WAS AT THAT TIME THAT THE DEVICE WAS REMOVED, AND GRAFTING WAS REQUIRED.
IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS IV, AND THEIR ORAL HYGIENE IS LISTED AS FAIR. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #11. DURING PLACEMENT OF THE DEVICE, THE PROVIDER WAS UNABLE TO ACHIEVE PRIMARY STABILITY. UPON EXAMINATION, THE PROVIDER NOTED THE SITE HAD BONE LOSS AND THE IMPLANT WAS REMOVED. THE PROVIDER DETERMINED THAT THE IMPLANT LACKED STABILITY AND THAT GRAFTING WAS REQUIRED.
IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS IV, AND THEIR ORAL HYGIENE IS LISTED AS FAIR. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TEETH #11 AND #12. THE PATIENT RETURNED ON AN UNKNOWN DATE. UPON EXAMINATION, THE PROVIDER NOTED THE SITE HAD DEHISCENCE AND THE IMPLANT WAS REMOVED. THE PROVIDER DETERMINED THAT THE IMPLANT LACKED STABILITY AND THAT GRAFTING WAS REQUIRED. ALSO, ONE OF THE IMPLANTS FAILED DURING IMPLANT PLACEMENT, AND THE OTHER FAILED WITHIN THREE WEEKS OF IMPLANT PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2330960 | INCLUSIVE TAPERED IMPLANT 3.7 MMD X 10 MML X 3.5 MMP | INCLUSIVE TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1070-IMP0006 | 6092132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Required Intervention |