ZFX, GENTEK TIBASE, TSV/TM ENGAGING, 3.5MMD X 4.7MMH
Report
- Report Number
- 3008932779-2025-00026
- Event Type
- Malfunction
- Date Received
- August 5, 2025
- Date of Event
- June 4, 2025
- Report Date
- April 2, 2026
- Manufacturer
- ZFX GMBH
- Product Code
- NHA
- PMA / PMN Number
- K231915
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5. DESCRIBE EVENT OR PROBLEM. D9: DEVICE AVAILABILITY . G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H10: ADDED MANUFACTURER NARRATIVE.
ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. A3: GENDER UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED . D4: LOT/SERIAL # UNKNOWN / NOT PROVIDED . D4: DEVICE EXPIRATION DATE UNKNOWN / NOT PROVIDED. D4: DEVICE UDI NUMBER UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.
ZFX DID NOT RECEIVE ITEM ZFX11-ZB-TSV-3547-EL FOR EVALUATION. THE CUSTOMER DID SUBMIT IMAGES FOR THE REPORTED EVENT. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE IMAGES RECEIVED. ONE PACKAGE ZFX11-ZB-TSV-3547-EL WITH LOT 0000230523 WAS CONTROLLED BY INCOMING INSPECTION AND INCLUDED POM-SCREW, TI-SCREW AND TI-BASE WAS APPROVED ON 30.05.2023 WITHOUT DEVIATIONS. BASED ON IMAGES RECEIVED, THE HEX FROM TI-BASE SEEMS TORN BUT IS NOT BROKEN. IF THE CROWN¿T-BASE ASSEMBLY DOES NOT SEAT PASSIVELY, STRESS IS TRANSFERRED TO THE SCREW AND THE T-BASE INTERFACE. THE FOLLOWING CONSEQUENCES CAN RESULT FROM ERRORS LIKE THIS: SCREW BENDING, MICRO-MOVEMENT AND/OR FATIGUE FRACTURE OF THE TI-BASE. AN EXPLANATION IS, THAT, AFTER THE SCREW IS SCREWED DOWN INTERNAL TENSIONS REMAINS BECAUSE THE CROWN DOES NOT SEAT PERFECTLY. OCCUSAL FORCES AMPLIFY THIS STRESS. THE HEX FROM TI-BASE SEEMS TO BE BROKEN. (2) PICTURES OF THE SCREW ARE RECEIVED. IT CAN BE CONCLUDED FROM THE PICTURES, THAT SCREW IS BENT. A SCREW GET LOOSENING AND/OR BEND, WHEN WE HAVE A INCORRECT TIGHTENING TORQUE, A NON PASSIVE FIT OF THE ZIRCONA CROWNS, OR CEMENT CONTAMINATION BETWEEN CROWN AND TI-BASE. THESE ARE ALL POSSIBLE REASONS, THE CROWN MAY NOT FULLY SEAT AND THE SCREW AND TI-BASE BEARS THE CONSEQUENTIAL DAMAGES. FOUR (4) PICTURES OF AN IMPLANT PLACED INTO THE MOUTH ARE RECEIVED. PICTURES SHOWN THAT TI BASE WAS MILLED OUT INTO THE IMPLANT AND IMPLANT IS DAMAGED. ADDITIONALLY, A X-RAY PICTURE FOR THE AFFECTED DENTAL POSITION 36 WAS RECEIVED SHOWING THAT THE CROWN IS NOT CORRECTLY SEATED, WHICH CAN POTENTIALLY LEAD TO A FRACTURE. FOR THE FRACTURE IN POSITION 35, THE POSSIBLE ROOT CAUSES CAN BE: NON-PASSIVE FIT OF THE ZIRCONIA CROWN, INCORRECT TIGHTENING TOQUE, CEMENT CONTAMINATION BETWEEN CROWN AND TI-BASE, ANY MODIFICATION OF THE ABUTMENT CONNECTION (E.G. BLASTING) DURING CROWN PREPARATION. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED TI-BASE LOT NUMBER 0000230523 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE RMF-001 THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS AN INADEQUATE TREATMENT PLANNING, MISUNDERSTOOD OR OVERLOOKED INSTRUCTIONS FOR USE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION WAS NOT ESTABLISHED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER, G6: CHECKED "FOLLOW-UP", H2: CHECKED FOLLOW-UP TYPE, H6: ENTERED EVALUATION CODES, H11: ADDED MANUFACTURER NARRATIVE.
ZFX DID NOT RECEIVE ITEM ZFX11-ZB-TSV-3547-EL FOR EVALUATION. THE CUSTOMER DID SUBMIT IMAGES FOR THE REPORTED EVENT: VISUAL INSPECTION COULD BE PERFORMED ON PICTURES, PARTS ARE NOT SEND TO ZFX. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. PICTURES OF ITEM ZFX® GENTEK® TIBASE, TSV®/TRABECULAR METAL®, ENGAGING, 3.5MMD X 4.7MMH WITH A DENTAL CROWN ON THE TI-BASE. ADDITIONALLY PICTURES OF THE ONE (1) SCREW AND OF THE IMPLANT WERE RECEIVED. TIBASE PICTURE: TWO (2) PICTURES OF A TIBASE WITH A DENTAL CROWN ARE RECEIVED. THE HEX FROM TI-BASE SEEMS TORN, BUT IS NOT BROKEN. FROM THE PICTURE OF THE TI BASE WE CANNOT CONFIRM IF THE CONTACT SURFACE IS IN USABLE CONDITION OR WAS GROUNDED DOWN. TIBASE PICTURE: THREE (3) PICTURES OF A TIBASE WITH A DENTAL CROWN ARE RECEIVED. THE HEX FROM TI-BASE SEEMS TO BE BROKEN. FROM THE PICTURE OF THE TI BASE WE CANNOT CONFIRM IF THE CONTACT SURFACE IS IN USABLE CONDITION OR WAS GROUNDED DOWN. SCREW PICTURE: TWO (2) PICTURES OF THE THE SCREW ARE RECEIVED. IT CAN BE CONCLUDED FROM THE PICTURES, THAT SCREW IS BENT. IMPLANT PICTURE: THREE (3) PICTURES OF AN IMPLANT ARE RECEIVED. FROM PICTURE 2, IMPLANT IS CORRECT. FROM THE TWO OTHER PICTURES (PICTURES 1 AND 3) WE SEE IMPLANTS WITHOUT CHARACTERISTICS FROM A TSV-IMPLANT. NO OUTER HEX AND NO CONICAL CONTACT SURFACE. FROM PICTURE 1 AND 3 OF THE IMPLANT, WE CAN CONCLUDE THAT IT DOESN`T WORK WITH A TI-BASE. IN THIS IMPLANTS THE INTACT TI-BASE WITH HIS SCREW SHOULD WORK. THE DESCRIPTION IS NOT CLEARLY AT ALL. IF IT IS POSITION 35 OR 36 IS NOT COMPREHENSIBLE. IN THE DESCRIPTION IS WRITTEN THAT WE SEE THE BROKEN HEX FROM THE TI-BASE INTO THE IMPLANT, BUT WE DIDN`T. WE SEE THE CONTOURS FROM THE IMPLANT. AS LOT NUMBER IS NOT AVAILABLE, DHR AND COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED. BASED ON THE INVESTIGATION AN RISK MANAGEMENT FILE RMF-001 THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS A IMPLANT NOT COMPATIBLE WITH THE TI-BASE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION WAS ESTABLISHED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE.
IT WAS REPORTED THAT ABUTMENT WAS FRACTURED. IMPLANT IS IN THE MOUTH AND APPEARS NORMAL CLINICALLY AND RADIOGRAPHICALLY. IN THE CASE OF TOOTH 35, THE ABUTMENT FRACTURED, LEAVING A PORTION OF IT INSIDE THE IMPLANT (YOUR REPRESENTATIVE SAW WHAT HAPPENED BECAUSE WE CALLED HER DURING THE SURGERY WE PERFORMED TO OPEN THE SOFT TISSUE AND REMOVE THE FRACTURED SEGMENT). DATE OF FRACTURE ON TEETH 35 WAS (B)(6). TOOTH #35 WAS REHABILITATED BY USING A T-BASE ABUTMENT (PLACED IN (B)(6) 2024) TOOTH 35, THE PATIENT MANIFESTED MOBILITY IN SAID REHABILITATION ABOUT 4 WEEKS AGO AND WHEN REVIEWED IN CONSULTATION (B)(6), IT WAS CONFIRMED THAT THE CROWN WAS MOBILE. WHEN THE CROWN WAS UNSCREWED, IT WAS FOUND THAT THE THROUGH SCREW OF THE T-BASE PILLAR WAS COMPLETELY TWISTED, WHICH CAUSED THE MOBILITY AND DISLODGING OF THE CROWN. ONCE THIS PROBLEM WITH THE THROUGH SCREW WAS CONFIRMED, THE PATIENT WAS SCHEDULED FOR A NEW IMPRESSION YESTERDAY (B)(6) 2025), HOWEVER THE IMPRESSION ABUTMENT COULD NOT BE ESTABLISHED, SO SHE ASKED THE PERIODONTIST TO PERFORM A NEW SURGERY (BUT NOW FOR TOOTH 35) THAT ALLOWS US TO HAVE BETTER VISUAL ACCESS TO THE IMPLANT WHERE WE APPRECIATED THAT WHAT DID NOT ALLOW SUCH SETTLEMENT WAS A PART OF THE TBASE THAT WAS FRACTURED INSIDE THE IMPLANT.
IT WAS REPORTED THAT TOOTH #35 WAS REHABILITATED BY USING A T-BASE ABUTMENT (PLACED IN (B)(6) 2024), ALONG WITH THE CROWN OF THE FAILED TOOTH 36. THE IMPLANT IN TOOTH 36 PRESENTED A FRACTURE IN THE TBASE ABUTMENT, WHICH CAUSED THE MOBILITY OF THE CROWN AND THE SUBSEQUENT DISLODGING OF IT. TOOTH 35, THE PATIENT MANIFESTED MOBILITY IN SAID REHABILITATION ABOUT 4 WEEKS AGO AND WHEN REVIEWED IN CONSULTATION (B)(6), IT WAS CONFIRMED THAT THE CROWN WAS MOBILE. WHEN THE CROWN WAS UNSCREWED, IT WAS FOUND THAT THE THROUGH SCREW OF THE T-BASE PILLAR WAS COMPLETELY TWISTED, WHICH CAUSED THE MOBILITY AND DISLODGING OF THE CROWN. ONCE THIS PROBLEM WITH THE THROUGH SCREW WAS CONFIRMED, THE PATIENT WAS SCHEDULED FOR A NEW IMPRESSION YESTERDAY (B)(6) 2025), HOWEVER THE IMPRESSION ABUTMENT COULD NOT BE ESTABLISHED, SO SHE ASKED THE PERIODONTIST TO PERFORM A NEW SURGERY (BUT NOW FOR TOOTH 35) THAT ALLOWS US TO HAVE BETTER VISUAL ACCESS TO THE IMPLANT WHERE WE APPRECIATED THAT WHAT DID NOT ALLOW SUCH SETTLEMENT WAS A PART OF THE TBASE THAT WAS FRACTURED INSIDE THE IMPLANT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 257963 | ZFX, GENTEK TIBASE, TSV/TM ENGAGING, 3.5MMD X 4.7MMH | DENTAL ABUTMENT | NHA | ZFX GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |