ZFX, GENTEK TIBASE, CERTAIN ENGAGING, 4.1MMD X 4.7MMH
Report
- Report Number
- 3008932779-2025-00034
- Event Type
- Malfunction
- Date Received
- September 26, 2025
- Date of Event
- August 19, 2025
- Report Date
- November 7, 2025
- Manufacturer
- ZFX GMBH
- Product Code
- NHA
- PMA / PMN Number
- K231915
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G3: DATE RECEIVED BY MANUFACTURER . G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. ZFX RECEIVED ONE (1) ITEM GENTEK® HEXED GOLD-TITE SCREW, CERTAIN® WHICH IS THE SCREW CONTAINED IN THE FINAL PACKAGE OF ZFX11-ZB-CE-4147-EL. THE THREAD OF THE SCREW IS BROKEN AND IS NOT SEND TO ZFX, FOR EVALUATION. VISUAL EVALUATION / FUNCTIONAL TEST WAS PERFORMED: VISUAL EVALUATION: THE SCREW IS BROKEN. THE BROKEN THREAD IS RETURNED FOR AN EVALUATION. THE CONTACT SURFACE FROM THE SCREW ON THE SCREW HEAD AND THE HEX ARE IN USED CONDITION. THE SCREW WAS BROKEN ONE AND A HALF ROTATIONS UNDER THE BEGIN OF THE THREAD. THE SCREW HAS NORMAL SIGNS OF USE. FUNCTIONAL TEST: DIMENSIONS FROM DRAWING WERE MEASURED BY INDICATOR AND ALL MEASURABLE DIMENSIONS ARE WITHIN SPECIFICATION. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 0000230717 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL: FUNCTIONAL: FRACTURE: SCREW BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION THAT CLINICIAN INCORRECTLY ENGAGES ABUTMENT SCREW INTO IMPLANT (CROSS-THREADED) CAUSING THREAD DAMAGE RESULTING ON A SCREW FRACTURE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION WAS NOT ESTABLISHED. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE RESULTS FROM THE VISUAL/FUNCTIONAL INSPECTIONS. 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.
ZIMVIE COMPLAINT NUMBER (B)(4). D.4.: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. H.4.: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
THE DOCTOR REPORTED THAT A YEAR AFTER PLACEMENT OF THE PRODUCT, THE TITANIUM BASE SCREW FRACTURED BY THE BODY. PLACED ON (B)(6) 2024 AND REMOVED ON (B)(6) 2025. AFFECTED DENTAL POSITION 15.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2112746 | ZFX, GENTEK TIBASE, CERTAIN ENGAGING, 4.1MMD X 4.7MMH | DENTAL ABUTMENT | NHA | ZFX GMBH | 0000230717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Unknown |