MAUDE Adverse Event Report: ZFX GMBH GENTEK¿ ANGULATED SCREW CHANNEL TIBASE, CERTAIN® ENGAGING, 4.1MMD X 1.3MMCH; DENTAL TIBASE

Catalog Number	ZFX11ZB-CE41AS13E
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D4: expiration date: unknown / not provided.
Event or Problem Description
Doctor reported screw loosening.Placement date: (b)(6) 2025.Removal date: (b)(6) 2026.

• Brand Name: GENTEK¿ ANGULATED SCREW CHANNEL TIBASE, CERTAIN® ENGAGING, 4.1MMD X 1.3MMCH
• Common Device Name: DENTAL TIBASE
• Manufacturer (Section D): ZFX GMBH; kopernikusstr. 15; dachau 85221 ; GM 85221
• Manufacturer (Section G): ZFX GMBH; kopernikusstr. 15; dachau 85221 ; GM 85221
• Manufacturer Contact: ana leitão ; kopernikusstr. 15; dachau 85221 ; GM 85221 ; 0491623088254
• MDR Report Key: 25182846
• Report Number: 3008932779-2026-00020
• Device Sequence Number: 10693000
• Product Code: NHA
• UDI-Device Identifier: 04251881714364
• UDI-Public: (01)04251881714364(10)0000240507(240)ZFX11ZB-CE41AS13E
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K231915
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: ZFX11ZB-CE41AS13E
• Device Lot Number: 0000240507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic