HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
Report
- Report Number
- 3011649314-2024-00080
- Event Type
- Injury
- Date Received
- February 2, 2024
- Date of Event
- June 11, 2022
- Report Date
- March 14, 2025
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- DZE
- PMA / PMN Number
- K143353
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VM
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED FOR ANALYSIS. HOWEVER, THE EVALUATION OF THE DEVICE IS PENDING. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). SECTION E1 POST OFFICE OR ZIP CODE: (B)(6). SECTION E1 TELEPHONE NUMBER: (B)(6).
CORRECTED: A2, G3 (IN PREVIOUS SUBMISSION THE MISSING DATE OF G3 SHOULD BE (B)(6)2024). H6 (MEDICAL DEVICE PROBLEM CODE). ADDITIONAL INFORMATION: H6 (INVESTIGATION CONCLUSIONS). CAPA CA-00016. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
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#6102721 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: A REVIEW OF STOCK PRODUCT WAS PERFORMED FOR HAHN TAPERED IMPLANT LOT#6102721 AND FOUND NO ADDITIONAL PRODUCT IN STOCK TO 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 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. BONE DEBRIS AND BLOOD WAS OBSERVED IN THE THREADING OF THE IMPLANT. (SEE ATTACHED IMAGES). 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: "LOSS OF OSSEOINTEGRATION" 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 LOSS OF OSSEOINTEGRATION 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 3.0 (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 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." IFU 570 REV 3.0 (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 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." PER IFU- 570 REV 3.0 (HAHN TAPERED IMPLANT SYSTEM IFU), THE "IMPLANT PLACEMENT" SECTION STATES: "USE SLIGHT FINGER PRESSURE TO PINCH THE OCCLUSAL END OF THE IMPLANT IN ITS HOLDER WHILE INSERTING THE APPROPRIATE IMPLANT DRIVER. GENTLY ROTATE IMPLANT AND HOLDER, ALLOWING THE DRIVER TO ENGAGE THE IMPLANT CONNECTION. WITH THE DRIVER SECURELY ATTACHED TO THE IMPLANT, SQUEEZE THE OPPOSING END OF THE HOLDER TO DISENGAGE THE IMPLANT FROM THE HOLDER. TRANSPORT THE IMPLANT TO THE PREPARED SITE AND INSERT INTO THE OSTEOTOMY. ROTATE CLOCKWISE WITH APPLIED PRESSURE TO ENGAGE THE SELF-TAPPING GROOVES. AVOID LATERAL FORCES, WHICH CAN AFFECT THE ANGULATION AND FINAL ALIGNMENT OF THE IMPLANT. ADVANCEMENT AND FINAL SEATING - CONTINUE THREADING THE IMPLANT INTO THE OSTEOTOMY SITE USING THE PREFERRED PLACEMENT METHOD. A MINIMUM TORQUE VALUE OF 35 NCM UPON FINAL SEATING INDICATES GOOD PRIMARY STABILITY.
CORRECTED: G1 CONTINUED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
A HEALTHCARE PROFESSIONAL REPORTED THAT A HAHN TAPERED IMPLANT LOST INTEGRATION ON TOOTH #47. PER THE REPORTED INFORMATION THERE ARE NO PREEXISTING MEDICAL CONDITIONS. THE IMPLANT WAS REMOVED DUE TO FITTING ISSUE DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. A SECONDARY IMPLANT WAS PLACED AFTER REMOVAL. THE PATIENT'S BONE QUALITY IS TYPE IS D3 AND THE PATIENT'S ORAL HYGIENE STATUS IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1373158 | HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM | HAHN TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0011 | 6102721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | Required Intervention |