HAHN TAPERED IMPLANT Ø4.3 X 10 MM
Report
- Report Number
- 3011649314-2023-00705
- Event Type
- Injury
- Date Received
- November 2, 2023
- Date of Event
- August 7, 2023
- Report Date
- January 20, 2025
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- DZE
- PMA / PMN Number
- K143353
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THE DEVICE IS RETURNED, AN INVESTIGATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
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#6130164 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 THERE WAS NO STOCK PRODUCT FROM LOT#6130164 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS CUSTOMER HAS NOT RETURNED THE REPORTED DEVICE OR PROVIDED PICTURES FOR REVIEW TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE "LACK OF PRIMARY STABILITY" IS A COMMON COMPLAINT IN REGARD 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. IFU 570 REV 4.0 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE CONTRAINDICATIONS SECTION: "HAHN TAPERED IMPLANTS SHOULD NOT BE PLACED IN PATIENTS DISCOVERED TO BE MEDICALLY UNFIT FOR THE INTENDED TREATMENT. PRIOR TO CLINICAL INTERVENTION, PROSPECTIVE PATIENTS MUST BE THOROUGHLY EVALUATED FOR ALL KNOWN RISK FACTORS AND CONDITIONS RELATED TO ORAL SURGICAL PROCEDURES AND SUBSEQUENT HEALING. CONTRAINDICATIONS INCLUDE BUT ARE NOT LIMITED TO: VASCULAR CONDITIONS, UNCONTROLLED DIABETES, CLOTTING DISORDERS, ANTICOAGULANT THERAPY, METABOLIC BONE DISEASE, CHEMOTHERAPY OR RADIATION THERAPY, CHRONIC PERIODONTAL INFLAMMATION, INSUFFICIENT SOFT TISSUE COVERAGE, METABOLIC OR SYSTEMIC DISORDERS ASSOCIATED WITH WOUND AND/OR BONE HEALING, USE OF PHARMACEUTICALS THAT INHIBIT OR ALTER NATURAL BONE REMODELING, ANY DISORDERS WHICH INHIBIT A PATIENT'S ABILITY TO MAINTAIN ADEQUATE DAILY ORAL HYGIENE, UNCONTROLLED PARAFUNCTIONAL HABITS, INSUFFICIENT HEIGHT AND/OR WIDTH OF BONE, AND INSUFFICIENT INTERARCH SPACE." 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. CORRECTION - B5 DESCRIBE EVENT OR PROBLEM, E1 INITIAL REPORTER NAME AND ADDRESS, H4 DEVICE MANUFACTURE DATE.
A4 WAS INADVERTENTLY REPORTED AS 00 LBS IN THE INITIAL REPORT, HOWEVER, THIS INFORMATION WAS NOT REPORTED. CAPA CA-00016. CAPA 24-005. MANUFACTURER REFERENCE: COMP-(B)(4).
THE DEVICE INVESTIGATION HAS BEEN UPDATED AND THE RESULTS ARE AS FOLLOWS: STOCK PRODUCT REVIEWED RESULTS: THE STOCK PRODUCT FOR LOT#6130164 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED. INVESTIGATION METHODS/RESULTS: BASED ON THE TRACKING LABEL THE PRODUCT WAS NOTED AS NOT BEING PHYSICALLY ACCOUNTED FOR. THEREFORE, IT IS PRESUMED NOT SENT AT THIS TIME, CAPA 2024-005 WAS OPENED FOR PRODUCT NOT RECEIVED. THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE: "FAILURE TO OSSEOINTEGRATE" IS A COMMON COMPLAINT IN REGARD 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 (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 (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." CAPA CA-00016, CAPA 24-005. MANUFACTURER REFERENCE: (B)(4).
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED DUE TO LACK OF PRIMARY STABILITY. THE PATIENT'S BONE TYPE IS III AND THE PATIENT'S ORAL HYGIENE IS NOTED AS GOOD. THE PATIENT PRESENTED WITH THE ISSUE ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #10. THE IMPLANT WAS PLACED ON (B)(6) 2023 AND THE IMPLANT WAS REMOVED ON (B)(6) 2023. PATIENT EXPERIENCED INFLAMMATION AND PAIN. THE SYMPTOMS RESOLVED AFTER THE REMOVAL OF IMPLANT.
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS III AND THE PATIENT'S ORAL HYGIENE IS NOTED AS GOOD. THE PATIENT PRESENTED ON (B)(4) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #10. THE IMPLANT WAS THEN REMOVED ON (B)(4) 2023 DUE TO LACK OF PRIMARY STABILITY. PATIENT EXPERIENCED INFLAMMATION AND PAIN. THE SYMPTOMS RESOLVED AFTER THE REMOVAL OF IMPLANT.
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE. THE PATIENT'S BONE TYPE IS III AND THE PATIENT'S ORAL HYGIENE IS NOTED AS GOOD. THE PATIENT PRESENTED ON (B)(6) 2023 FOR AN IMPLANT PLACEMENT ON AN UNSPECIFIED TOOTH, HOWEVER, TOOTH #7 AND 10 WERE REFERENCED. DURING A FOLLOW-UP EXAMINATION ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFLAMMATION AND PAIN. THE IMPLANT WAS REMOVED THAT DAY AND REPLACED WITH HAHN TAPERED IMPLANT 3.5 X 10. THE SYMPTOMS RESOLVED AFTER THE REMOVAL OF IMPLANT. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL/SURGICAL PROCEDURE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1928086 | HAHN TAPERED IMPLANT Ø4.3 X 10 MM | HAHN TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0010 | 6130164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention |