MAUDE Adverse Event Report: SIN SISTEMA DE IMPLANTE NACIONAL S/A SIN IMPLANTE; DENTAL IMPLANT

Model Number	UCMC 4005N
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
Additional Manufacturer Narrative
These records are being submitted following the completion of the necessary system updates to correctly reflect the proper manufacturer information within section d.Configuration and validation documentation updates were required to enable submission of the manufacturer, sin sistema de implante nacional s/a, within section d and f along with the contact office information for biohorizons within section f.The updates supported the proper handling for future submissions.The records included in this submission reflect the originally reported devices provided to biohorizons.

• Brand Name: SIN IMPLANTE
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): SIN SISTEMA DE IMPLANTE NACIONAL S/A; rua soldado ocimar guimaraes; da silva, 421 vila rio branco; sao paulo ; BR
• MDR Report Key: 25280886
• Report Number: 1060818-2026-80007
• Device Sequence Number: 15894270
• Product Code: DZE
• UDI-Device Identifier: 07899995215819
• UDI-Public: 07899995215819
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/16/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: UCMC 4005N
• Device Catalogue Number: UCMC 4005N
• Device Lot Number: X040490506
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown