INCLUSIVE MINI IMPLANT O-BALL 2.2 MMD X 10 MML
Report
- Report Number
- 3011649314-2022-00545
- Event Type
- Injury
- Date Received
- October 7, 2022
- Date of Event
- August 25, 2022
- Report Date
- July 11, 2024
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- DZE
- PMA / PMN Number
- K121406
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THE DEVICE HAS BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT'S WEIGHT IS NOT RECORDED AT THE TIME OF THE OFFICE VISIT. PATIENT'S RACE IS NOT RECORDED AT THE TIME OF THE OFFICE VISIT. THIS IS THE 2ND OF 2 FAILED IMPLANTS REPORTED ON THE SAME PATIENT. REFERENCE THE FOLLOWING MANUFACTURER REPORTS FOR THE REMAINING IMPLANTS. 3011649314-2022-00547.
ADDITIONAL DATA: H6 (HEALTH EFFECT - CLINICAL CODE, AND TYPE OF INVESTIGATION CODES) CORRECTED DATA: B5, D4, H4, H6 (MEDICAL DEVICE PROBLEM CODE) CAPA 23-006. MANUFACTURER REFERENCE: (B)(4).
THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT# 6070562 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 A INCLUSIVE MINI IMPLANT O-BALL 2.2 MMD X 10 MML (70-1068-IMP0001) USING RADIOGRAPHIC TEMPLATE (GD-455-0612). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. BONE DEBRIS WAS OBSERVED ON THE IMPLANT. 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 4990 REV 1.0 (INCLUSIVE MINI 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." THE IFU ALSO 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 4990 REV 1.0 (INCLUSIVE MINI 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.
CORRECTION: SECTION B: B5: HAHN TAPERED IMPLANT WAS MENTIONED IN ERROR ON THE INITIAL SUBMISSION. THE ITEM SHOULD HAVE BEEN NOTED AS AN INCLUSIVE MINI IMPLANT O-BALL.
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS IV AND THEIR ORAL HYGIENE IS LISTED AS POOR. THE PATIENT HAS A HISTORY OF SMOKING. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #3. THE PATIENT RETURNED ON (B)(6) 2022 WITH COMPLAINTS OF PAIN. UPON EXAMINATION, THE PROVIDER NOTED INFECTION AND GRANULATED/FIBROUS TISSUE AROUND THE IMPLANT. THE PROVIDER DETERMINED THAT THE IMPLANT LOSS INTEGRATION AND THE DEVICE WAS REMOVED. BASED ON THE DATES NOTED IN THE QUESTIONNAIRE COMPLETED BY THE PROVIDER, MEDICAL OPINION WAS SOUGHT, AND IT WAS DETERMINED THAT BECAUSE OF THE TIME THAT HAD LAPSED BETWEEN WHEN THE IMPLANT WAS PLACED AND REMOVED, THE IMPLANT FAILED TO INTEGRATE.
IT WAS REPORTED THAT THE INCLUSIVE MINI IMPLANT O-BALL IMPLANT FAILED. THE PATIENT'S BONE TYPE IS IV AND THEIR ORAL HYGIENE IS LISTED AS POOR. THE PATIENT HAS A HISTORY OF SMOKING. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #3. THE PATIENT RETURNED ON (B)(6) 2022 WITH COMPLAINTS OF PAIN. UPON EXAMINATION, THE PROVIDER NOTED INFECTION AND GRANULATED/FIBROUS TISSUE AROUND THE IMPLANT. THE PROVIDER DETERMINED THAT THE IMPLANT LOST INTEGRATION AND THE DEVICE WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 246364 | INCLUSIVE MINI IMPLANT O-BALL 2.2 MMD X 10 MML | INCLUSIVE MINI IMPLANT O-BALL | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1068-IMP0001 | 6070562 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Required Intervention |