HAHN TAPERED IMPLANT Ø3.5 X 8 MM
Report
- Report Number
- 3011649314-2023-00234
- Event Type
- Injury
- Date Received
- April 24, 2023
- Date of Event
- March 1, 2023
- Report Date
- February 4, 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 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.
THE DEVICE WAS RETURNED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT#: 6113522 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#: 6113522 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 Ø3.5 X 8MM (70-1154-IMP0004) 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: "LOSS OF OSSEOINTEGRATION" 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 LOSS OF OSSEOINTEGRATION IS INCONCLUSIVE AND SPECIFIC TO EACH CASE, PROBABLE CAUSES COULD BE THE LOSS OF PRIMARY STABILITY AT THE OSTEOTOMY SITE 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 DIABETES AND HYPERTENSION. 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. 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 3.0 (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." CORRECTION: A1 PATIENT IDENTIFIER CORRECTED.
ADDITIONAL INFORMATION: H6 (HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS). CORRECTED INFORMATION: B3, B5, D4, E1, G1, H6 (HEALTH EFFECT - IMPACT CODE). D6B WAS REPORTED IN THE INITIAL REPORT AS 03/23/2023, HOWEVER, THE IMPLANT WAS EXPULSED AND NOT EXPLANTED. H6: MEDICAL DEVICE PROBLEM CODE 4627 WAS REPORTED IN THE INITIAL REPORT, HOWEVER, THE IMPLANT WAS EXPULSED AND NOT EXPLANTED. H6: HEALTH EFFECT - CLINICAL CODE 1908 WAS REPORTED IN THE INITIAL REPORT, HOWEVER, THIS CONDITION WAS NOT RELATED TO THE FAILED IMPLANT. MW 3011649314-2023-00233 CAPTURES THE OTHER REPORTED EVENT. CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).
THE DEVICE INVESTIGATION HAS BEEN UPDATED AND THE RESULTS ARE AS FOLLOWS: STOCK PRODUCT REVIEWED RESULTS THE STOCK PRODUCT FOR LOT #6113522 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 IMPLANTØ3.5 X 8 MM (70-1154-IMP0004) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED, AND THE THREADS WERE INTACT. MATTER 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 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 FAILURE TO OSSEOINTEGRATE IS INCONCLUSIVE AND SPECIFIC TO EACH CASE, PROBABLE CAUSES COULD BE THE LOSS OF PRIMARY STABILITY AT THE OSTEOTOMY SITE 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. IFU-570 REV 3 (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" A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. PROBABLE ROOT CAUSE IS IMPROPER SEATING OF THE IMPLANT DRIVER INTO THE INTERNAL HEX OF THE IMPLANT. IT IS UNCLEAR THE METHODS OF IMPLANT PLACEMENT USED DURING THE INITIAL PROCEDURE OR IF APPROPRIATE LOAD DISTRIBUTION WAS OBSERVED. IFU 570 REV 5 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE IMPLANT PLACEMENT SECTION: "STEP 2: INITIAL PLACEMENT - ENGAGE THE IMPLANT CONNECTION WITH THE APPROPRIATE DRIVER. WITH THE IMPLANT SECURELY ATTACHED TO THE DRIVER, 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. STEP 3: 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." IFU 570 REV 3.0 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE METHODS OF IMPLANT PLACEMENT SECTION: "OPTION 1: HANDPIECE IMPLANT PLACEMENT - PLACE THE APPROPRIATE IMPLANT DRIVER INTO THE HANDPIECE. SEAT THE DRIVER INTO THE INTERNAL HEX CONNECTION OF THE IMPLANT AND PRESS FIRMLY TO FULLY ENGAGE THE CONNECTION. THREAD THE IMPLANT INTO THE OSTEOTOMY AT APPROXIMATELY 25 RPM UNTIL FULLY SEATED. OPTION 2: MANUAL IMPLANT PLACEMENT - ASSEMBLE THE ADJUSTABLE TORQUE WRENCH WITH THE SURGICAL ADAPTOR AND APPROPRIATE IMPLANT DRIVER. WITH THE IMPLANT THREADED SECURELY IN ITS SITE, SEAT THE DRIVER INTO THE INTERNAL HEX CONNECTION OF THE IMPLANT, AND PRESS FIRMLY TO FULLY ENGAGE THE CONNECTION. TURN THE WRENCH CLOCKWISE IN INCREMENTS OF APPROXIMATELY 90 DEGREES. AVOID LATERAL FORCES, WHICH CAN AFFECT FINAL ALIGNMENT OF THE IMPLANT." CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).
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 DIABETES AND HYPERTENSION. THE PATIENT PRESENTED ON (B)(6) 2022, FOR A PRIMARY PROCEDURE ON TOOTH #12. THE PATIENT RETURNED ON (B)(6) 2023, WITH THE STATEMENT THAT THE IMPLANT FELT VERY LOOSE AND SHE WAS ABLE TO REMOVE IT BY HAND. UPON EXAMINATION, THE PROVIDER NOTED INFLAMMATION, GRANULATION/FIBROUS TISSUE, AND ABNORMAL BONE LOSS AROUND THE IMPLANT, AND IT WAS DETERMINED THAT THE IMPLANT FAILED TO INTEGRATE. BASED ON THE DATES NOTED IN THE QUESTIONNAIRE COMPLETED BY THE PROVIDER, A MEDICAL OPINION WAS SOUGHT, AND IT WAS DETERMINED THAT BECAUSE OF THE TIME THAT HAD LAPSED BETWEEN WHEN THE DEVICE WAS PLACED AND REMOVED, THE IMPLANT HAD LOST INTEGRATION.
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 #10. THE PATIENT RETURNED ON (B)(6) 2023 WITH THE IMPLANT IN HAND. UPON EXAMINATION, THE PROVIDER NOTED INFLAMMATION, GRANULATION/FIBROUS TISSUE, AND ABNORMAL BONE LOSS AROUND THE IMPLANT, AND IT WAS DETERMINED THAT THE IMPLANT FAILED TO INTEGRATE. THE IMPLANT WAS NOT REPLACED, THERE WAS NO PERMANENT PATIENT INJURY AND NO ADDITIONAL MEDICAL/SURGICAL PROCEDURE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1442671 | HAHN TAPERED IMPLANT Ø3.5 X 8 MM | HAHN TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0004 | 6113522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention |