HAHN TAPERED IMPLANT Ø7.0 X 10 MM
Report
- Report Number
- 3011649314-2023-00157
- Event Type
- Injury
- Date Received
- March 16, 2023
- Date of Event
- December 14, 2022
- Report Date
- June 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
- WA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
CAPA 2023-006. THE DEVICE WAS RETURNED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT# 6080946 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 FOR LOT# 6080946 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 Ø7.0 X 10 MM (70-1154-IMP0020) 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. ROOT CAUSE: "LACK OF PRIMARY STABILITY" 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 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. PER THE REPORTED INFORMATION, THE PATIENT HAS A HISTORY OF SMOKING. IFU 570 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." IFU 570 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.
CORRECTION: D4 UNIQUE IDENTIFIER (UDI)# CORRECTED FROM (B)(4).
ADDITIONAL INFORMATION: B5, H6. CORRECTED INFORMATION: E1, G1. CAPA CA-00016. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
THE DEVICE HAS BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES.
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS III, AND THEIR ORAL HYGIENE IS LISTED AS GOOD. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #30. THE PATIENT RETURNED ON (B)(6) 2022, BEFORE THE SECOND STAGE OF SURGERY, WITH COMPLAINTS OF PAIN. UPON EXAMINATION, THE PROVIDER NOTED INFLAMMATION AND INFECTION. IT WAS DETERMINED THAT THE IMPLANT LACKED STABILITY, AND THE DEVICE WAS REMOVED AND NOT REPLACED. THE SYMPTOMS RESOLVED AFTER IMPLANT REMOVAL AND THERE WAS NO PERMANENT PATIENT INJURY. NO ADDITIONAL MEDICAL/SURGICAL PROCEDURE WAS REQUIRED.
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS III, AND THEIR ORAL HYGIENE IS LISTED AS GOOD. THE PATIENT HAS A HISTORY OF SMOKING. THE PATIENT PRESENTED ON (B)(6) 2022 FOR A PRIMARY PROCEDURE ON TOOTH #30. THE PATIENT RETURNED ON (B)(6) 2022, BEFORE THE SECOND STAGE OF SURGERY, WITH COMPLAINTS OF PAIN. UPON EXAMINATION, THE PROVIDER NOTED INFLAMMATION AND INFECTION. IT WAS DETERMINED THAT THE IMPLANT LACKED STABILITY, AND THE DEVICE WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664383 | HAHN TAPERED IMPLANT Ø7.0 X 10 MM | HAHN TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0020 | 6080946 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Required Intervention |