HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
Report
- Report Number
- 3011649314-2026-00298
- Event Type
- Injury
- Date Received
- February 20, 2026
- Date of Event
- December 29, 2025
- Report Date
- April 13, 2026
- 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
COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, SHOULD THE DEVICE BE RETURNED, AN INVESTIGATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). LINKED TO MDR #3011649314-2026-00297.
THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR HAHN TAPERED IMPLANT LOT# 6110671 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# 6110671 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN THE ORIGINAL PACKAGE. AN ABUTMENT WAS ATTACHED TO THE IMPLANT. THE IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM (70-1154-IMP0011) USING THE RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. MATTER WAS OBSERVED IN THE TREADING OF THE IMPLANT. THE COMPLAINT IS VERIFIED BASED ON THE RETURNED PART 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 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 HAD A HISTORY OF SMOKING BUT STOPPED SMOKING 10 YEARS AGO. THE PATIENT ALSO HAS TYPE II BONE QUALITY. 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." IFU-570 REV 3 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE SURGICAL PROCEDURES UNDER THE PRECAUTION SECTION: "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 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE 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) CONTAINS THE FOLLOWING STATEMENT IN THE 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 THE REPORTED INFORMATION, THERE WAS A FIT ISSUE AS WELL. THE PROBABLE CAUSE FOR THIS ISSUE MAY BE DUE TO AN OVER PREPARED OSTEOTOMY. IFU-570 REV 3 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE SITE PREPARATION SECTION: "IF PLACING A HAHN TAPERED IMPLANT THAT IS 3.5 MM IN DIAMETER OR GREATER, SHAPING DRILLS ARE USED SEQUENTIALLY TO WIDEN THE OSTEOTOMY TO THE MATCHING DIAMETER. TO AVOID OVER-PREPARATION, WIDENING DRILL DIAMETERS SHOULD BE USED ONLY AS NEEDED, AND IN PROPER SUCCESSION. EACH SHAPING DRILL IS LENGTH-SPECIFIC, TO MATCH THE LENGTH OF THE PRESCRIBED IMPLANT. OSTEOTOMY DEPTH MAY BE INCREASED SEQUENTIALLY, BEGINNING WITH SHORTER DRILL LENGTHS, PROVIDED SUFFICIENT DEPTH IS ACHIEVED WITH THE FINAL DRILL. SELECT THE DESIRED SHAPING DRILL, ACCOUNTING FOR BONE DENSITY AND THE SIZE OF THE IMPLANT TO BE PLACED. WITH COPIOUS IRRIGATION, DRILL TO DEPTH. THE FINAL DRILL SHOULD CORRESPOND WITH THE MATCHING IMPLANT SIZE, AS CHARTED BELOW, WITH THE GOAL OF ACHIEVING HIGH PRIMARY STABILITY UPON IMPLANT PLACEMENT." ADDITIONAL INFORMATION: D9 THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). RELATED MDR NUMBER: 3011649314-2026-00297, 3011649314-2026-00431.
ON (B)(6) 2026, DR. (B)(6) = REPORTED THAT A 62-YEAR-OLD MALE PATIENT PRESENTED TO HIS LUMI DENTAL STUDIO OFFICE WITH CONCERNS RELATED TO A PREVIOUSLY PLACED DENTAL IMPLANTS. THE PRIMARY IMPLANT PLACEMENT SURGERY, USING A HAHN TAPERED IMPLANT AT TOOTH LOCATIONS #5 AND #30, WAS PERFORMED ON (B)(6) 2025. THE DOCTOR DISCOVERED THAT AT THE SECOND STAGE SURGERY, THE IMPLANTS HAD NOT INTEGRATED WELL, AFTER HEALING ABUTMENT PLACEMENT AND DURING THE OBSERVATION, THE IMPLANTS WERE FOUND TO BE LOOSE. THE PATIENT SUBSEQUENTLY RETURNED ON (B)(6) 2025, AT WHICH TIME THE IMPLANTS FAILED TO OSSEOINTEGRATE AND A FIT ISSUE WAS NOTICED. IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED, AND THE SITES ARE CURRENTLY HEALING PRIOR TO A NEW IMPLANT SURGERY. THE PATIENT REMAINED ASYMPTOMATIC, DID NOT SUFFER ANY PERMANENT INJURY, AND DID NOT REQUIRE ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THE IMPLANTS HAVE NOT YET BEEN REPLACED. THE PATIENT'S BONE QUALITY IS CLASSIFIED AS TYPE II, WITH GOOD ORAL HYGIENE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468830 | HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM | HAHN TAPERED IMPLANT SYSTEM | DZE | PRISMATIK DENTALCRAFT, INC. | 70-1154-IMP0011 | 6110671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Required Intervention |