HAHN TAPERED IMPLANT Ø4.3 X 13 MM
Report
- Report Number
- 3011649314-2023-00493
- Event Type
- Injury
- Date Received
- July 20, 2023
- Date of Event
- May 1, 2023
- Report Date
- March 26, 2025
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- DZE
- PMA / PMN Number
- K143353
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
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. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES. SECTION A: A4: PATIENT'S WEIGHT WAS NOT PROVIDED.
ADDITIONAL INFORMATION: D5, D9, E1 (ESTABLISHMENT NAME), H3, H6 (HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). CORRECTED INFORMATION: B3, B5, D6A, D6B, E1 (TELEPHONE NUMBER, FAX, ADDRESS), G1, H6 (MEDICAL DEVICE PROBLEM CODE). THE DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION HAS BEEN COMPLETED. THE RESULTS ARE AS FOLLOWS: DHR RESULTS: PER THE REPORTED INFORMATION CORRECT LOT NUMBER COULD NOT BE IDENTIFIED. HOWEVER, TWO LOT NUMBERS WERE PROVIDED AS A POSSIBLE LOT NUMBER FOR DEVICE. DHR REVIEW WAS PERFORMED ON EACH LOT NUMBER. ORIGINAL LOT NUMBER GIVEN ON PIQ: 6111911. THE DHR WAS REVIEWED FOR HAHN TAPERED IMPLANT LOT# 6111911 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. LOT NUMBER GIVEN IN EMAIL RESPONSE FROM PROVIDER DATED 10-21-23: 6079508. THE DHR WAS REVIEWED FOR HAHN TAPERED IMPLANT LOT# 6079508 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: PER THE REPORTED INFORMATION ON THE PIQ, LOT NUMBER 6111911 HAD A MANUFACTURING DATE OF 03-11-2022, WHICH WAS NOTED TO BE AFTER THE IMPLANT PLACEMENT DATE OF (B)(6) 2022; THEREFORE, NO STOCK PRODUCT REVIEW WAS PERFORMED. ON 11-29-2023 AN EMAIL WAS RECEIVED UPDATING THE IMPLANT PLACEMENT DATE TO (B)(6) 2023 AND A REVIEW OF STOCK PRODUCT WAS PERFORMED, AND NO ADDITIONAL PRODUCT WAS IN STOCK. PER THE REPORTED INFORMATION VIA AN EMAIL RECEIVED ON 10-21-2023, POSSIBLE LOT NUMBER 6079508 WAS PROVIDED, AND STOCK PRODUCT REVIEW WAS PERFORMED AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN THE ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø4.3 X 13 MM (70-1154-IMP0012) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. MATTER WAS OBSERVED IN THE THREADING OF THE IMPLANT. THERE WAS NO EVIDENCE FOUND THAT INDICATED THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF. PER THE REPORTED INFORMATION CORRECT LOT NUMBER COULD NOT BE IDENTIFIED, HOWEVER TWO LOT NUMBERS WERE PROVIDED AS A POSSIBLE LOT NUMBER FOR THE DEVICE. THE ORIGINAL LOT NUMBER GIVEN PER PIQ (LOT# 6111911) INDICATED A DEVICE MANUFACTURING DATE (3-11-2022) THAT WAS AFTER THE REPORTED IMPLANT PLACEMENT DATE ((B)(6) 2022). THEREFORE, THIS LOT NUMBER COULD NOT HAVE BEEN PLACED ON 2-01-2022. ON 10-21-23 VIA EMAIL, THE LOT NUMBER GIVEN (# 6079508) INDICATED A DEVICE MANUFACTURING DATE OF 2-7-2020; THE 10-21-2023 EMAIL FROM PROVIDER, HOWEVER, INDICATED IDENTICAL PRODUCT NUMBERS FOR TWO DIFFERENT SIZED PRODUCTS. ON 11-29-2023 AN EMAIL WAS RECEIVED, AND LOT NUMBER GIVEN 6111911 INDICATED A DEVICE SIZE OF Ø4.3 X 13 MM WHICH WAS DISCREPANT WITH THE REPORTED DEVICE SIZE OF Ø4.3 X 10 MM. ROOT CAUSE: "FAILURE TO OSSEOINTEGRATE" IS A COMMON COMPLAINT WITH 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. PER THE REPORTED INFORMATION PATIENT HAS A HISTORY OF DIABETES AND PERIODONTITIS. IFU-570 REV 3 (LOT NUMBER 6111911) AND REV 2 (LOT NUMBER 6079508) (HAHN TAPERED IMPLANT SYSTEM) EACH CONTAIN 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 3 (LOT NUMBER 6111911) AND REV 2 (LOT NUMBER 6079508) (HAHN TAPERED IMPLANT SYSTEM) EACH CONTAIN 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." IFU-570 REV 3 (LOT NUMBER 6111911) AND REV 2 (LOT NUMBER 6079508) (HAHN TAPERED IMPLANT SYSTEM) EACH CONTAIN 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 3 (LOT NUMBER 6111911) AND REV 2 (LOT NUMBER 6079508) (HAHN TAPERED IMPLANT SYSTEM) EACH CONTAIN 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. FOR BEST RESULTS, PLEASE OBSERVE THE FOLLOWING PRECAUTIONS: ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL, 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." ADDITIONAL REPORTS RELATED TO THIS COMPLAINT: 3011649314-2023-00491, 3011649314-2023-00492, 3011649314-2023-00518. 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 NOTED AS GOOD. THE PATIENT HAS A HISTORY OF DIABETES AND PERIODONTITIS. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #27. THE PATIENT RETURNED ON (B)(6) 2023, AT THE SECOND STAGE OF SURGERY AFTER THE FINAL PROSTHESIS DELIVERY WITHOUT COMPLAINT. UPON EXAMINATION, THE PROVIDER NOTED GRANULATED/FIBROUS TISSUE AND BONE LOSS AROUND THE IMPLANT. IT WAS DETERMINED THAT THE IMPLANT FAILED TO INTEGRATE, AND THE DEVICE WAS REMOVED. BASED ON THE DATES NOTED IN THE QUESTIONNAIRE COMPLETED BY THE PROVIDER, A MEDICAL OPINION WAS SOUGHT, AND IT WAS DETERMINED THAT BECAUSE OF THE TIME THAT HAD LAPSED BETWEEN WHEN THE DEVICE WAS PLACED AND REMOVED, THE IMPLANT HAD LOST INTEGRATION.
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS II, AND THEIR ORAL HYGIENE IS NOTED AS GOOD. THE PATIENT HAS A HISTORY OF DIABETES AND PERIODONTITIS. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #27. THE PATIENT RETURNED ON (B)(6) 2023, AT THE SECOND STAGE OF SURGERY AFTER THE FINAL PROSTHESIS DELIVERY WITHOUT COMPLAINT. UPON EXAMINATION, THE PROVIDER NOTED GRANULATED/FIBROUS TISSUE AND BONE LOSS AROUND THE IMPLANT. IT WAS DETERMINED THAT THE IMPLANT FAILED TO INTEGRATE, AND THE DEVICE WAS REMOVED AND NOT REPLACED. THE SYMPTOMS RESOLVED AFTER IMPLANT REMOVAL, THEIR WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL/SURGICAL PROCEDURE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36336 | HAHN TAPERED IMPLANT Ø4.3 X 13 MM | HAHN TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0012 | 6111911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | Required Intervention |