HAHN TAPERED IMPLANT 5.0 MM X 8MM
Report
- Report Number
- 3011649314-2022-00025
- Event Type
- Injury
- Date Received
- February 25, 2022
- Date of Event
- January 11, 2022
- Report Date
- June 3, 2024
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- DZE
- PMA / PMN Number
- K143353
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THERE IS MORE INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PATIENTS WEIGHT IS NOT PROVIDED AS IT IS NOT TAKEN AT THE TIME OF THE APPOINTMENT.
THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THERE IS MORE INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PATIENTS WEIGHT IS NOT PROVIDED AS IT IS NOT TAKEN AT THE TIME OF THE APPOINTMENT.
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# 6093575 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 COULD BE CONFIRMED. INVESTIGATION METHODS/RESULTS: CUSTOMER HAS NOT RETURNED THE REPORTED DEVICE FOR REVIEW TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE: "FAILURE TO OSSEOINTEGRATE" 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 3027904 REV 3.0 (HAHN TAPERED 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. 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." IFU 3027904 REV 3.0 (HAHN TAPERED 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 3027904 REV 3.0 (HAHN TAPERED 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."
CORRECTED INFORMATION: B5, D4, H6 (HEALTH EFFECT - IMPACT CODE, INVESTIGATION FINDINGS CODE, AND INVESTIGATION CONCLUSIONS CODE -4315). ADDITIONAL INFORMATION: B1, H6 (TYPE OF INVESTIGATION CODE AND INVESTIGATION CONCLUSIONS CODE -22). H1 WAS CORRECTED IN THE PREVIOUS REPORT BUT NOT NOTATED IN SECTION H11. CAPA 23-006. MANUFACTURER REFERENCE: (B)(4).
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE BONE GRADE IS NOTED AS GRADE UNKNOWN. THE PATIENT HAS A MEDICAL HISTORY OF "KIDNEY DISEASE AND IS A SMOKER." THERE IS NO DENTAL HISTORY NOTED, WITH THE EXCEPTION OF MISSING SEVERAL UPPER TEETH. THE PATIENT PRESENTED ON (B)(6) 2021 FOR IMPLANT PLACEMENT ON TOOTH #4. THE PATIENT RETURNED (B)(6) 2022 THREE WEEKS AFTER PLACEMENT WITHOUT COMPLAINT. UPON EXAM, THE PROVIDER CONFIRMS A FAILURE TO INTEGRATE. IT WAS AT THAT TIME THE DEVICE WAS REMOVED, BUT NOT REPLACED.
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE BONE GRADE IS NOTED AS GRADE UNKNOWN. THE PATIENT HAS A MEDICAL HISTORY OF "KIDNEY DISEASE AND IS A SMOKER." THERE IS NO DENTAL HISTORY NOTED, WITH THE EXCEPTION OF MISSING SEVERAL UPPER TEETH. THE PATIENT PRESENTED ON (B)(6) 2021 FOR IMPLANT PLACEMENT ON TOOTH #4. THE PATIENT RETURNED (B)(6) 2022 THREE WEEKS AFTER PLACEMENT WITHOUT COMPLAINT. UPON EXAM, THE PROVIDER CONFIRMS A FAILURE TO INTEGRATE. IT WAS AT THAT TIME THE DEVICE WAS REMOVED, BUT NOT REPLACED.
THE PATIENT PRESENTED FOR IMPLANT PLACEMENT ON TOOTH #29.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1334749 | HAHN TAPERED IMPLANT 5.0 MM X 8MM | HAHN TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0014 | 6093575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Required Intervention |