ZFX, GENTEK TIBASE, TSV/TM NON ENGAGING, 3.5MMD X 4.7MMH
Report
- Report Number
- 3008932779-2025-00036
- Event Type
- Malfunction
- Date Received
- September 26, 2025
- Report Date
- November 14, 2025
- Manufacturer
- ZFX GMBH
- Product Code
- NHA
- PMA / PMN Number
- K231915
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. A2: AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED. A3: GENDER UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. D10. CONCOMITANT MEDICAL PRODUCTS ZFX09-ZB-TSV-RS, ZFX, GENTEK RETAINING SCREW, TSV/TM LOT 2120031732. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.
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 TWO (2) SCREW HEADS FROM SCREW ZFX GENTEK RETAINING SCREW, TSV/TRABECULAR METAL, THIS TYPE OF SCREW IS PART OF THE PACKAGE (B)(4) WHICH INCLUDESTHIS TI-SCREW, A POM SCREW AND THE TI-BASE. FROM THE TWO SCREW HEADS RECEIVED, ZFX CANNOT CONFIRM WHICH ONE CORRESPONDS TO THE SCREW PACKAGED WITH (B)(4) OR TO THE SCREW AS A FINAL PRODUCT ZFX09-ZB-TSV-RS. THE SCREWS ARE THE SAME DRAWING MATCH, SO IT CAN NOT BE ASSIGNED TO A CASE AND THE SELECTION WAS MADE ARBITRARILY. VISUAL INSPECTION: THE SCREW IS BROKEN UNDER THE SCREW HEAD. THE REST OF THE SCREW HAS NOT BEEN SENT TO ZFX. FRACTURE SITS FROM THE SCREW SHOWS SWING FRACTURE, CAUSED PROBABLY BY UNILATERAL BENDING , CAUSED BY UNILATERAL BENDING. THE SCREW HEAD IS IN USED CONDITION AND HAS SCRATCHES. THE CONTACT SURFACE ON THE UNDERSIDE OF THE SCREWHEAD IS IN USED CONDITION, NO ABNORMALITIES FOUND. FUNCTIONAL TEST: THE SCREW HEAD IS FUNCTIONALLY OK. DIMENTIONALLY IT WORKS, THE INNER HEX IS IN USABLE CONDITION. COMPLAINT HISTORY REVIEW WAS WAS PERFORMED FOR THE REPORTED LOT NUMBER 2120020317 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 WAS FRACTURE. THE EXACTLY ROOT CAUSE FROM FRACTURE CAN NOT BE DETERMINED WITH THIS INFORMATION. ¿THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR AS NO DEVIATION WERE FOUND THROUGH THE VISUAL AND FUNCTIONAL EVALUATION. THE SCREW WAS FRACTURED. THE REPORTED EVENT WAS CONFIRMED. 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 DOCTOR REPORTS THAT THE DENTAL SCREWS FRACTURED BY THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303006 | ZFX, GENTEK TIBASE, TSV/TM NON ENGAGING, 3.5MMD X 4.7MMH | DENTAL SCREW | NHA | ZFX GMBH | 2120020317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DENTAL SCREW . |