GLIDEWELL HT IMPLANT Ø3.5 X 8 MM
Report
- Report Number
- 3011649314-2025-00778
- Event Type
- Injury
- Date Received
- July 17, 2025
- Date of Event
- May 28, 2025
- Report Date
- December 24, 2025
- Manufacturer
- PRISMATIK DENTALCRAFT
- Product Code
- DZE
- PMA / PMN Number
- K143353
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, 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 LOT# 6220372, 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 IS NO STOCK PRODUCT FROM LOT # 6220372 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED, BUT NOT IN THE ORIGINAL PACKAGE. THE IMPLANT HOLDER WAS ALSO RETURNED. THE IMPLANT WAS VERIFIED TO BE A GLIDEWELL HT IMPLANT Ø3.5 X 8 MM (70-1189-IMP0004) USING THE RADIOGRAPHIC TEMPLATE (MKT-013579 REV 1 PK-4500230-112023). 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 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. 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 A FIT ISSUE AS WELL. THE PROBABLE CAUSE FOR THIS ISSUE MAY BE DUE TO AN OVER PREPARED OSTEOTOMY. IFU-012631 IF PLACING A GLIDEWELL HT 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. THE MANUFACTURER'S INTERNAL REFERENCE NUMBER IS: (B)(4). THE REPORT FOR THE ADDITIONAL REPORTED DEVICE IS FOUND IN THE FOLLOWING MEDWATCH REPORT: 3011649314-2025-01509. CORRECTIONS: B5: "DESCRIBE EVENT OR PROBLEM" H6: UPDATED "TYPE OF INVESTIGATION" CODE H6: UPDATED "INVESTIGATION FINDINGS" CODE. H6: UPDATED "INVESTIGATION CONCLUSIONS" CODE.
THE RELATED MDR IS 3011649314-2025-00771.
THE DEVICE WAS RETURNED FOR ANALYSIS. HOWEVER, THE EVALUATION OF THE DEVICE IS PENDING. SEVERAL ATTEMPTS HAVE BEEN MADE TO PROVIDER TO OBTAIN ADDITIONAL, WITHOUT RESPONSE. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4). THE REPORT FOR THE ADDITIONAL REPORTED DEVICE IS FOUND IN THE FOLLOWING MEDWATCH REPORT: 3011649314-2025-00772. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4).
THE CUSTOMER REPORTED THAT TWO GLIDEWELL HT IMPLANTS FAILED. THE PATIENT CAME IN FOR A PRIMARY PROCEDURE ON TOOTH # 4 ON (B)(6) 2025. DURING IMPLANT PLACEMENT, THE PROVIDER DETERMINED THE IMPLANT EXPERIENCED A FITTING ISSUE AND LACKED PRIMARY STABILITY; GRANULATION AND ABNORMAL BONE LOSS AROUND THE IMPLANT WERE OBSERVED. THE IMPLANTS WERE REMOVED THE SAME DAY AND REPLACED WITH A LARGER SIZE IMPLANT. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE PERMANENT INJURY.
THE CUSTOMER REPORTED THAT A GLIDEWELL HT IMPLANT WAS DEFECTIVE. THE PATIENT'S BONE QUALITY IS TYPE I AND THE PATIENT'S ORAL HYGIENE IS REPORTED AS POOR. THE PATIENT CAME IN FOR A PRIMARY PROCEDURE ON TOOTH #4 ON (B)(6) 2025. DURING IMPLANT PLACEMENT, THE PROVIDER DETERMINED THE IMPLANT HAD LACKED PRIMARY STABILITY; GRANULATION / FIBROUS TISSUE AROUND THE IMPLANT AND ABNORMAL BONE LOSS WERE DETECTED. THE IMPLANT WAS REMOVED AND REPLACED WITH A LARGER IMPLANT. THE SECOND IMPLANT ALSO FAILED AND WAS ALSO REPLACED WITH A LARGER IMPLANT. THE PATIENT HAD NO PERMANENT INJURY. A FOLLOW UP WITH THE CUSTOMER CONFIRMED THAT BOTH IMPLANTS WERE FOR THE SAME TOOTH LOCATION (#5). IT WAS CONFIRMED THAT THE EXPLANT DATE FOR BOTH WAS THE SAME AS THE IMPLANT DATE (B)(6) 2025).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 671131 | GLIDEWELL HT IMPLANT Ø3.5 X 8 MM | GLIDEWELL HT TAPERED IMPLANT | DZE | PRISMATIK DENTALCRAFT | 70-1189-IMP0004 | 6220372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention |