HAHN TAPERED IMPLANT Ø3.5 X 13 MM
Report
- Report Number
- 3011649314-2024-00155
- Event Type
- Injury
- Date Received
- February 28, 2024
- Date of Event
- February 8, 2024
- Report Date
- March 27, 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
DEVICE EVALUATION HAS BEEN COMPLETED; FOLLOWING IS THE DEVICE ANALYSIS CONCLUSION: DHR RESULTS: THE DHR WAS REVIEWED FOR HAHN TAPERED IMPLANT LOT#6111907 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#6111907 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED. INVESTIGATION METHODS/RESULTS: PRODUCT WAS NOTED TO HAVE BEEN RECEIVED AND IN GLIDEWELL'S POSSESSION; HOWEVER, THE DEVICE HAS NOT BEEN PHYSICALLY ACCOUNTED FOR AND SENT TO THE COMPLAINT'S TEAM FOR ANALYSIS. THEREFORE, IT IS PRESUMED LOST AT THIS TIME, CAPA 2024-005 WAS OPENED FOR RMA LOST PRODUCT. THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE: "LACK OF PRIMARY STABILITY" IS A COMMON COMPLAINT IN REGARD 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. PREMATURE LOADING, PATIENT'S HEALTH, PERI-IMPLANTITIS, SMOKING, AND LACK OF ORAL HYGIENE MAY ALSO BE CONTRIBUTING FACTORS. IFU-570 REV 3 (HAHN TAPERED IMPLANT SYSTEM IFU) 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 3 (HAHN TAPERED IMPLANT SYSTEM IFU) 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 3 (HAHN TAPERED IMPLANT SYSTEM IFU) 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 3 (HAHN TAPERED IMPLANT SYSTEM IFU) 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."
THE COMPLAINT DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PROBABLE OR ROOT CAUSE OF THE EVENT HAS NOT BEEN IDENTIFIED. MANUFACTURER'S INTERNAL REFERENCE NUMBER: (B)(4).
CORRECTED: D9, H3, H6, G3 (THE G3 IN THE PREVIOUS SUBMISSION WAS INADVERTENTLY LEFT BLANK, IT SHOULD BE 01/03/2025). ADDITIONAL INFORMATION: A4. CAPA CA-00016. CAPA 24-005. MANUFACTURER'S INTERNAL REFERENCE NUMBER: (B)(4).
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
A HEALTHCARE PROFESSIONAL REPORTED A HAHN TAPERED IMPLANT LACKED PRIMARY STABILITY DURING IMPLANT PLACEMENT ON TOOTH NUMBER 5. THE IMPLANT WAS REMOVED DURING THE SAME SURGICAL PROCEDURE WITH NO OBSERVABLE CLINICAL SYMPTOMS REPORTED. A SECONDARY IMPLANT WAS NOT PLACED AFTER REMOVAL. IT WAS REPORTED THAT AT THE TIME OF THE SURGICAL PROCEDURE THE PATIENT'S BONE QUALITY WAS TYPE I WITH A HEALTHY HEALTH STATUS. THE PATIENT'S ORAL HYGIENE STATUS IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 932250 | HAHN TAPERED IMPLANT Ø3.5 X 13 MM | HAHN TAPERED IMPLANT SYSTEM | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0007 | 6111907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | Required Intervention |