HAHN TAPERED IMPLANT Ø4.3 X 10 MM
Report
- Report Number
- 3011649314-2023-00186
- Event Type
- Injury
- Date Received
- April 4, 2023
- Date of Event
- April 4, 2022
- Report Date
- February 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
- MA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS THE DHR WAS REVIEWED FOR LOT#6102719 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#6102719 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT 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. BONE DEBRIS WAS OBSERVED IN THE THREADING OF THE IMPLANT. 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. 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." 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."
ADDITIONAL INFORMATION: B1, B2, B5, H6. CORRECTED INFORMATION: A2, G1, H1. CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).
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 IS NOT RECORDED AT THE TIME OF THE OFFICE VISIT.
IT WAS REPORTED THAT HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS I AND THEIR ORAL HYGIENE IS GOOD. THERE IS NO MEDICAL OR DENTAL HISTORY BEFORE IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2021 FOR A PRIMARY PROCEDURE ON TOOTH #13. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RETURNED ON (B)(6) 2022, AFTER HEALING ABUTMENT PLACEMENT, WITH COMPLAINT OF PAIN. THE PATIENT RETURNED ON (B)(6) 2022 AND THE PROVIDER DETERMINED THAT THE IMPLANT FAILED TO INTEGRATE AND THE DEVICE WAS REMOVED.
IT WAS REPORTED THAT HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS I AND THEIR ORAL HYGIENE IS GOOD. THERE IS NO MEDICAL OR DENTAL HISTORY BEFORE IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2021 FOR A PRIMARY PROCEDURE ON TOOTH #13. THE PATIENT RETURNED ON (B)(6) 2022, AFTER HEALING ABUTMENT PLACEMENT WITHOUT COMPLAINT. THE PATIENT RETURNED ON (B)(6) 2022 AND THE PROVIDER DETERMINED THAT THE IMPLANT FAILED TO INTEGRATE AND THE DEVICE WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387146 | HAHN TAPERED IMPLANT Ø4.3 X 10 MM | HAHN TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0010 | 6102719 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Required Intervention |