MAUDE Adverse Event Report: ZFX GMBH GENTEK¿ ANGULATED SCREW CHANNEL TIBASE, TSV®/TM¿ ENGAGING, 3.5MMD X 1.3MMCH; DENTAL ABUTMENT

Catalog Number	ZFX11ZB-TSV35AS13E
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reported that the prosthesis kept coming loose despite multiple tightenings and screw changes.No impact on the patient reported.This event represents one of the multiple tightening of the screw.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).B3: date of event unknown / not provided d4: expiration date unknown / not provided d9: device availability unknown / not provided.

• Brand Name: GENTEK¿ ANGULATED SCREW CHANNEL TIBASE, TSV®/TM¿ ENGAGING, 3.5MMD X 1.3MMCH
• Common Device Name: DENTAL ABUTMENT
• 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: 25296384
• Report Number: 3008932779-2026-00021
• Device Sequence Number: 21155751
• Product Code: NHA
• UDI-Device Identifier: 04251881714609
• UDI-Public: (01)04251881714609(10)0000250205(240)ZFX11ZB-TSV35AS13E
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/27/2026

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-TSV35AS13E
• Device Lot Number: 0000250205
• Was Device Available for Evaluation?: No
• 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: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic