GLIDEWELL HT IMPLANT Ø4.3 X 16 MM
Report
- Report Number
- 3011649314-2025-01184
- Event Type
- Injury
- Date Received
- October 6, 2025
- Date of Event
- July 22, 2025
- Report Date
- December 12, 2025
- Manufacturer
- PRISMATIK DENTALCRAFT
- 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 INVESTIGATION HAS BEEN COMPLETED, AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR GLIDEWELL HT IMPLANT LOT# 6231152, 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 GLIDEWELL HT IMPLANT LOT# 6231152 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN THE ORIGINAL PACKAGE. A DENTAL PROSTHETIC WAS ATTACHED TO THE IMPLANT. THE IMPLANT WAS VERIFIED TO BE A GLIDEWELL HT IMPLANT Ø4.3 X 16 MM (70-1189-IMP0013) USING THE RADIOGRAPHIC TEMPLATE (MKT-013579 REV 1 PK-4500230-112023). IT WAS OBSERVED THAT THERE WAS A FRACTURE AT THE ABUTMENT AREA THAT WAS HOLDING THE DENTAL PROSTHETIC. THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED ON THE IMPLANT, 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 DESCRIPTION: "LACK OF PRIMARY STABILITY", "FAILURE TO OSSEOINTEGRATE", AND "LOSS OF OSSEOINTEGRATION" ARE COMMON COMPLAINTS REGARDING 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, FAILURE TO OSSEOINTEGRATE, AND LACK OF OSSEOINTEGRATION ARE 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 TYPE IV BONE QUALITY AND FAIR ORAL HYGIENE. IFU-012631 REV 1 (GLIDEWELL HT IMPLANT SYSTEM IFU) CONTAINS THE FOLLOWING STATEMENT IN THE CONTRAINDICATIONS SECTION: "GLIDEWELL HT 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-012631 REV 1 (GLIDEWELL HT IMPLANT SYSTEM IFU) 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. THE 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-012631 REV 1 (GLIDEWELL HT IMPLANT SYSTEM IFU) CONTAINS THE FOLLOWING STATEMENT IN THE WARNINGS SECTION: "THE IMPLANT SITE SHOULD BE INSPECTED FOR ADEQUATE BONE BY RADIOGRAPHS, PALPATION, 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-012631 REV 1 (GLIDEWELL HT IMPLANT SYSTEM IFU) CONTAINS THE FOLLOWING STATEMENT IN THE WARNINGS 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." PER THE REPORTED INFORMATION, THERE WAS AN IMPLANT FRACTURE AT OR AFTER THE DELIVERY OF THE PROSTHESIS/ABUTMENT, BUT BASED ON THE RETURNED IMPLANT, IT WAS OBSERVED THAT THERE WAS A FRACTURE AT THE ABUTMENT AREA OF THE DENTAL PROSTHETIC. A POTENTIAL ROOT CAUSE IS THE OVER-TORQUING OF THE PROSTHETIC, WHICH MAY HAVE CAUSED A FRACTURE. ADDITIONALLY, IT IS UNCLEAR WHAT METHODS OF PLACEMENT WERE USED DURING THE PROCEDURE AND THE INSERTION TORQUE VALUE. THE MANUFACTURER'S INTERNAL REFERENCE NUMBER IS: (B)(4). CORRECTIONS: B5: "DESCRIBE EVENT OR PROBLEM" H3: "DEVICE EVALUATED BY MANUFACTURER" H6: UPDATED "TYPE OF INVESTIGATION" CODE. H6: UPDATED "INVESTIGATION FINDINGS" CODE. H6: UPDATED "INVESTIGATION CONCLUSIONS" CODE.
THE DEVICE WAS RETURNED FOR ANALYSIS HOWEVER, THE EVALUATION OF THE DEVICE IS PENDING. ONCE AN INVESTIGATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4).
ON (B)(6) 2025, THE PATIENT PRESENTED FOR A PRIMARY PROCEDURE ON TOOTH # 10. THE PATIENT RETURNED WITHIN THREE WEEKS OF IMPLANT PLACEMENT ON (B)(6) 2025, THE PROVIDER OBSERVED INFLAMMATION AND AN INFECTION PRESENT, IT WAS DETERMINED THAT THE IMPLANT LACKED PRIMARY STABILITY. IT WAS ALSO REPORTED THAT THE IMPLANT FAILED TO OSSEOINTEGRATION AND A LOSS OF OSSEOINTEGRATION. IT WAS ALSO REPORTED THAT THE IMPLANT FRACTURED AFTER THE DELIVERY OF THE PROSTHESIS/ABUTMENT. THE IMPLANT WAS REMOVED AND NOT REPLACED. IT WAS REPORTED THAT THE PATIENT SYMPTOMS WERE RESOLVED AFTER IMPLANT REMOVAL. NO PERMANENT INJURY WAS REPORTED. THE PATIENT BONE TYPE WAS REPORTED AS TYPE III AND THEIR ORAL HYGIENE WAS REPORTED AS FAIR.
ON (B)(6) 2025, THE PATIENT PRESENTED FOR A PRIMARY PROCEDURE ON TOOTH # 10. THE PATIENT RETURNED WITHIN THREE WEEKS OF IMPLANT PLACEMENT ON (B)(6) 2025, THE PROVIDER OBSERVED INFLAMMATION AND AN INFECTION PRESENT, IT WAS DETERMINED THAT THE IMPLANT LACKED PRIMARY STABILITY. IT WAS ALSO REPORTED THAT THE IMPLANT FRACTURED AFTER THE DELIVERY OF THE PROSTHESIS/ABUTMENT. THE IMPLANT WAS REMOVED AND NOT REPLACED. IT WAS REPORTED THAT THE PATIENT SYMPTOMS WERE RESOLVED AFTER IMPLANT REMOVAL. NO PERMANENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7015 | GLIDEWELL HT IMPLANT Ø4.3 X 16 MM | GLIDEWELL HT IMPLANT SYSTEM | DZE | PRISMATIK DENTALCRAFT | 70-1189-IMP0013 | 6231152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Female | Required Intervention |