HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
Report
- Report Number
- 3011649314-2023-00583
- Event Type
- Injury
- Date Received
- October 9, 2023
- Date of Event
- August 17, 2023
- Report Date
- June 2, 2025
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- DZE
- PMA / PMN Number
- K143353
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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 HAHN TAPERED IMPLANT LOT#6120944 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 STOCK PRODUCT FOR HAHN TAPERED IMPLANT LOT#6120944 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED. 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 11.5 MM (70-1154-IMP0011) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. 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 "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 DIABETES, HYPERTENSION AND ARTHRITIS. 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 - D9 DEVICE AVAILABLE FOR EVALUATION, H4 DEVICE MANUFACTURE DATE.
THE DEVICE HAS BEEN RETURNED. AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT WAS IMPLANTED ON TOOTH NUMBER 12. THE PLACEMENT DATE IS (B)(6) 2023. DURING PLACEMENT OF THE DEVICE THERE WAS LACK OF PRIMARY STABILITY. IT WAS EXPLANTED (B)(6) 2023 AND THE IMPLANT WAS NOT REPLACED. BONE QUALITY IS TYPE IV AND ORAL HYGIENE IS GOOD.
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT WAS IMPLANTED ON TOOTH NUMBER 12. THE PATIENT'S BONE QUALITY IS TYPE IV, AND ORAL HYGIENE IS GOOD. THE PATIENT WAS INITIALLY PRESENTED ON (B)(6) 2023. DURING THE PLACEMENT OF THE DEVICE, THERE WAS A LACK OF PRIMARY STABILITY AND SPINNING IN THE OSTEOTOMY WITH 15NCM. THE DEVICE WAS EXPLANTED AND NOT REPLACED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL/SURGICAL PROCEDURES, AND NO OTHER PERMANENT INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291785 | HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM | HAHN TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0011 | 6120944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention |