HAHN TAPERED IMPLANT 4.3 X 10MM
Report
- Report Number
- 3011649314-2022-00030
- Event Type
- Injury
- Date Received
- March 8, 2022
- Date of Event
- September 28, 2021
- Report Date
- January 13, 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 BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE FIRST OF SIX IMPLANT COMPLAINTS, SEE MANUFACTURER REPORT FOR THE REMAINING COMPLAINT: 3011649314-2022-00031, 3011649314-2022-00032, 3011649314-2022-00033, 3011649314-2022-00034, 3011649314-2022-00035.
THE DEVICE WAS RETURNED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS; THE DHR WAS REVIEWED FOR LOT# 6091038 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 HAHN TAPERED IMPLANT Ø4.3 X 10 MM (70-1154-IMP0010) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. MINIMAL BONE DEBRIS WAS OBSERVED ON THE IMPLANT. (SEE ATTACHED IMAGES) THE COMPLAINT IS VERIFIED BASED ON THE RETURNED PART(S) BUT CANNOT CONFIRM THE FAILURE MODE. THERE WAS NO EVIDENCE FOUND THAT INDICATED THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF. 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." PER THE REPORTED INFORMATION, THE PATIENT HAD A HISTORY OF DIABETES AND BRUXISM. IFU 3027904 REV 3.0 (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."
CORRECTED INFORMATION: B5, D4, E1. THERE WAS A TOTAL OF 3 LOT NUMBERS FOR HAHN TAPERED IMPLANTS 3.5 X 10 AND 4.3 X 10 REPORTED FOR FIVE TOOTH LOCATIONS, #4, 12, 20, 22, AND 28. THE REPORTER DID NOT IDENTIFY WHICH LOT NUMBER WAS USED ON WHICH TOOTH. CAPA 23-006. MANUFACTURER REFERENCE: (B)(4).
CORRECTED INFORMATION: B5, D4, G1, G3 IN THE INITIAL REPORT WAS REPORTED AS 02/14/2022, HOWEVER, THE CORRECT DATE IS 02/03/2022. CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED TO INTEGRATE. THE PATIENT HAS A HISTORY OF DIABETES, METABOLIC BONE DISEASE/OSTEOPOROSIS AND BRUXISM. ALSO NOTED IS A HISTORY OF SMOKING. THE BONE GRADE IS NOTED AS GRADE III AND THERE IS "POOR" ORAL HYGIENE. THE PATIENT PRESENTED ON (B)(6) 2021 FOR PRIMARY PLACEMENT ON TOOTH #4. THE PATIENT RETURNED ON (B)(6) 2021 WITH COMPLAINTS OF PAIN. UPON EXAM THE PROVIDER NOTED INFLAMMATION, INFECTION, ABNORMAL BONE LOSS AROUND THE IMPLANT, SINUS PERFORATION AND A FAILURE TO INTEGRATE. IT WAS AT THAT TIME THE DEVICE WAS REMOVED BUT NOT REPLACED. THE PAIN RESOLVED AFTER THE REMOVAL OF THE IMPLANT.
THE PATIENT PRESENTED FOR PRIMARY PROCEDURE BUT THE SPECIFIC TOOTH NUMBER COULD NOT BE CONFIRMED. UPON FOLLOW-UP EXAM THE PROVIDER NOTED GRANULATION / FIBROUS TISSUE AROUND THE IMPLANT AND ABNORMAL BONE LOSS AROUND THE IMPLANT. THE SYMPTOMS RESOLVED AFTER THE REMOVAL OF THE IMPLANT.
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED TO INTEGRATE. THE PATIENTS BONE GRADE IS NOTED AS GRADE III AND THERE IS POOR ORAL HYGIENE. THE PATIENT PRESENTED ON (B)(6) 2021 FOR PRIMARY PLACEMENT. THE SPECIFIC TOOTH COULD NOT BE CONFIRMED. THE PATIENT RETURNED ON (B)(6) 2021 WITH COMPLAINTS OF PAIN. UPON EXAM THE PROVIDER NOTED INFLAMMATION, INFECTION, GRANULATION / FIBROUS TISSUE AROUND THE IMPLANT, ABNORMAL BONE LOSS AROUND THE IMPLANT, AND A FAILURE TO INTEGRATE. IT WAS AT THAT TIME THE DEVICE WAS REMOVED BUT NOT REPLACED. THE SYMPTOMS RESOLVED AFTER THE REMOVAL OF THE IMPLANT. THERE WAS NO PERMANENT PATIENT INJURY AND NO ADDITIONAL MEDICAL/SURGICAL PROCEDURE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 780104 | HAHN TAPERED IMPLANT 4.3 X 10MM | HAHN TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0010 | 6091038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention |