GenTek® Angulated Screw Channel TiBase, Certain® Engaging, 4.1mmD x 1.3mmCH ZFX11ZB-CE41AS13ERecalls & reported problems
Zfx GmbH · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04251881714364), received between Jan 8, 2026 and May 15, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (5 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Movement5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Inflammation1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Unintended Movement
DOCTOR REPORTED SCREW LOOSENING. PLACEMENT DATE: (B)(6) 2025. REMOVAL DATE: (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25182846 ↗MalfunctionFeb 5, 2026Unintended Movement
IT WAS REPORTED THAT THE SCREW LOOSENED AND WAS REMOVED. TOOTH LOCATION 14, TI BASE PLACED ON (B)(6) 2024 AND REMOVED ON (B)(6) 2026. THE PROSTHETIC COMPONENT WAS SLIGHTLY MOBILE. GINGIVAL INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS COMPLETED WITH ANOTHER SCREW.
Patient problems: Inflammation; Pain
MAUDE report 24266380 ↗MalfunctionJan 8, 2026Unintended Movement
DOCTOR REPORTED CONSTANT SCREW LOOSENING AT TOOTH SITE 37. A NEW SCREW WAS PLACED. THIS REPORT REFERS TO FIRST LOOSENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003586 ↗MalfunctionJan 8, 2026Unintended Movement
DOCTOR REPORTED CONSTANT SCREW LOOSENING AT TOOTH SITE 37. A NEW SCREW WAS PLACED. THIS REPORT REFERS TO FINAL LOOSENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003367 ↗MalfunctionJan 8, 2026Unintended Movement
DOCTOR REPORTED SCREW LOOSENING AT TOOTH SITE 46. PROCEDURE WAS COMPLETED AND A NEW SCREW WAS PLACED. SCREW PLACED ON (B)(6) 2023 AND REMOVED ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24002987 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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