MAUDE Adverse Event Report: ZFX GMBH ZFX, GENTEK TIBASE, TSV/TM NON ENGAGING, 3.5MMD X 4.7MMH; DENTAL ABUTMENT

Catalog Number	ZFX11-ZB-TSV-3547-NEL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number cmp-(b)(4).D10.Concomitant medical products zfx11-zb-tsv-3547-nel, zfx, gentek tibase, tsv/tm non engaging, 3.5mmd x 4.7mmh, lot number 2120020315 g1.Contact office (and manufacturing site for devices) or compounding outsourcing facility.& contact office - manufacturer site.
Event or Problem Description
It was report that the fixed dental bridge, originally cemented on (b)(6) 2025, exhibited persistent mobility.On (b)(6) 2025, the prosthetic restoration became detached, and two prosthetic screws were found fractured from implants at tooth #45-47.Furthermore, the abutment tooth 45 was clinically assessed as severely damaged, rendering it unsuitable for continued prosthetic support.

• Brand Name: ZFX, GENTEK TIBASE, TSV/TM NON ENGAGING, 3.5MMD X 4.7MMH
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZFX GMBH; kopernikusstr. 15; dachau FL 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: 24518781
• Report Number: 3008932779-2026-00000
• Device Sequence Number: 18564840
• Product Code: NHA
• UDI-Device Identifier: 04251881713848
• UDI-Public: (01)04251881713848(10)2120020315(240)ZFX11-ZB-TSV-3547-NEL
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• 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: Other
• Device Catalogue Number: ZFX11-ZB-TSV-3547-NEL
• Device Lot Number: 2120020315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/13/2026; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT SEE H10 NARRATIVE
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic