HAHN TAPERED IMPLANT Ø3.5 X 10 MM
Report
- Report Number
- 3011649314-2025-00577
- Event Type
- Injury
- Date Received
- June 19, 2025
- Date of Event
- March 20, 2025
- Report Date
- August 29, 2025
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- DZE
- PMA / PMN Number
- K143353
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE EVALUATION IS PENDING. AT THE COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE ANALYSIS CONCLUSION. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED; DOCUMENTATION INDICATES THE PRODUCT MET RELEASE CRITERIA. THE PROBABLE ROOT CAUSE OF THE EVENT HAS NOT YET BEEN IDENTIFIED. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).
THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT#6201827 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 LOT#6201827 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 10 MM (70-1154-IMP0005) 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. (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 DESCRIPTION: "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. PER THE REPORTED INFORMATION, THE PATIENT HAS A HISTORY OF BRUXISM. IFU-570 REV 4 (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 4 (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 4 (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 4 (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." A ROOT CAUSE FOR FIT ISSUE 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. IN REVIEWING RPT- 6367 REV 6.0 - RISK MANAGEMENT REPORT FOR INCLUSIVE TITANIUM ABUTMENTS AND SCREWS, THE REPORTED ISSUE HAS ALREADY BEEN IDENTIFIED UNDER THE "CUSTOMER RELATED" PROCESS ASPECT: · FAILURE MODE - ABUTMENT AND/OR SCREW DO NOT FIT/ PERFORM/ FUNCTION AS INTENDED. · CAUSE - INCORRECT COMPONENTS USED. · EFFECTS - COMPONENTS NOT ENGAGING CORRECTLY. · SEVERITY - 3 (SERIOUS- DEVICE FAILURE RESULTS IN INJURY OR IMPAIRMENT REQUIRING PROFESSIONAL MEDICAL INTERVENTION.) · OCCURRENCE - 2 (UNLIKELY- SPECIAL CAUSE EVENTS TYPICALLY ASSOCIATED WITH HUMAN ERROR OR UNEXPECTED ANOMALIES IN THE MANUFACTURING PROCESS OR DESIGN. WILL ONLY OCCUR WITH SMALL NUMBER OF DEVICES UNDER UNUSUAL CIRCUMSTANCES.) · RISK MITIGATION - REFER TO MANUFACTURER'S INSTRUCTIONS FOR USE - RECOMMENDED TORQUE VALUES LISTED IN THE "DENTAL IMPLANT COMPATIBILITY" LISTED IN THE PRODUCT IFU REFER TO "CONTRAINDICATIONS" IN THE PRODUCT IFU FOR ABUTMENT DESIGN PARAMETERS. LABEL ON PACKAGING STATES PRODUCT NAME AND SIZE. · RPN FINAL - 6 (UNACCEPTABLE RISK). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
A HEALTHCARE PROFESSIONAL REPORTED A HAHN TAPERED IMPLANT HAD A FIT ISSUE AND LACKED PRIMARY STABILITY DURING IMPLANT PLACEMENT ON TOOTH NUMBER 13. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER DID NOT OBSERVE ANY PATIENT SYMPTOMS OR PERMANENT INJURY. PER THE REPORT THE DEVICE WAS REMOVED, AND IT WAS REPLACED WITH A PRODUCT SIMILAR TO THE COMPLAINT PRODUCT WITHOUT PERMANENT INJURY OR ADDITIONAL PROCEDURES PERFORMED. IT WAS REPORTED THAT AT THE TIME OF THE SURGICAL PROCEDURE THE PATIENT'S BONE QUALITY WAS TYPE II WITH GOOD ORAL HYGIENE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1911692 | HAHN TAPERED IMPLANT Ø3.5 X 10 MM | HAHN TAPERED IMPLANT SYSTEM | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0005 | 6201827 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Required Intervention |