HAHN TAPERED IMPLANT 5.0 X 10 MM
Report
- Report Number
- 3011649314-2023-00167
- Event Type
- Injury
- Date Received
- March 22, 2023
- Date of Event
- February 15, 2023
- Report Date
- February 5, 2025
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- DZE
- PMA / PMN Number
- K143353
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
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#6092538 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 A REVIEW OF STOCK PRODUCT WAS PERFORMED FOR HAHN TAPERED IMPLANT LOT#6092538 AND FOUND NO ADDITIONAL PRODUCT IN STOCK TO REVIEW. INVESTIGATION METHODS/RESULTS CUSTOMER HAS NOT RETURNED THE COMPLAINT PART FOR INVESTIGATION 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. IFU 570 REV 4.0 (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 570 REV 4.0 (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 570 REV 4.0 (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. A3 SEX CORRECTED TO MALE.
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.
ADDITIONAL INFORMATION: H6 (HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION). CORRECTED INFORMATION: B5, G1, G3, H6 (INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). D6B IN THE INITIAL REPORT WAS REPORTED AS (B)(6)2023, HOWEVER, THE DEVICE WAS NOT EXPLANTED; PATIENT PRESENTED WITH THE IMPLANT IN HAND. G3 IN THE INITIAL REPORT WAS INADVERTENTLY REPORTED AS (B)(6)2023, HOWEVER, THE CORRECT DATE IS (B)(6)2023. H6 HEALTH EFFECT - IMPACT CODE 4627 WAS REPORTED IN THE INITIAL REPORT, HOWEVER, THE DEVICE WAS EXPULSED AND NOT EXPLANTED. CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS II, 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) 2021 FOR A PRIMARY PROCEDURE ON TOOTH #14. THE PATIENT RETURNED ON (B)(6) 2023, 18 MONTHS AFTER THE FINAL PROSTHESIS, COMPLAINING OF PAIN WITH THE IMPLANT IN HAND. UPON EXAMINATION, THE PROVIDER NOTED INFLAMMATION, GRANULATION/FIBROUS TISSUE AROUND THE IMPLANT, AND SINUS PERFORATION. IT WAS DETERMINED THAT THE IMPLANT HAD LOST INTEGRATION, AND THE DEVICE WAS REMOVED.
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS II, 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)2021 FOR A PRIMARY PROCEDURE ON TOOTH #14. THE PATIENT RETURNED ON (B)(6)2023, 18 MONTHS AFTER THE IMPLANT, COMPLAINING OF PAIN AND WITH THE IMPLANT IN HAND. UPON EXAMINATION, THE PROVIDER NOTED INFLAMMATION, GRANULATION/FIBROUS TISSUE AROUND THE IMPLANT, AND SINUS PERFORATION. IT WAS DETERMINED THAT THE IMPLANT HAD LOST INTEGRATION. THE SYMPTOMS HAVE RESOLVED AND THERE WAS NO PERMANENT PATIENT INJURY. THE IMPLANT WAS NOT REPLACED AND NO ADDITIONAL MEDICAL/SURGICAL PROCEDURE WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANT CAME OUT ON (B)(6)2023 AND THE PATIENT WAS SEEN BY THE PROVIDER THE SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 427284 | HAHN TAPERED IMPLANT 5.0 X 10 MM | HAHN TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0015 | 6092538 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Required Intervention |