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

Catalog Number	ZFX11-ZB-TSV-3547-EL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.D4: additional device information unknown / not provided.D9: device availability unknown / not provided.
Event or Problem Description
It was reported a fracture of the indexed hexagonal part of the ti-base at tooth site 36 inside the implant, leaving the implant separated from the crown.It was impossible to replace the crown and the implant was removed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie did not receive one (1) zfx-zb-tsv-3547-el for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number and risk management file.On (b)(6) 2023 we tested the lot 0000231019 at incoming inspection.No errors was found.Complaint history review was performed for the reported lot number 0000231018 for similar events and no other complaint was identified.Review completed utilizing keywords: screw fracture.The customer did not submit images for the reported event.Without device receipt, the reported event is non-verifiable 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.

• Brand Name: ZFX, GENTEK TIBASE, TSV/TM ENGAGING, 3.5MMD X 4.7MMH
• Common Device Name: DENTAL SCREW
• 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: 21959813
• Report Number: 3008932779-2025-00011
• Device Sequence Number: 18454847
• Product Code: NHA
• UDI-Device Identifier: 04251881713824
• UDI-Public: (01)04251881713824(10)0000231018(240)ZFX11-ZB-TSV-3547-EL
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: ZFX11-ZB-TSV-3547-EL
• Device Lot Number: 0000231018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic