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

Model Number	ILCM 3511
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.

• Brand Name: S.I.N IMPLANT
• 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 03348 -060; BR 03348-060
• MDR Report Key: 25716408
• Report Number: 1060818-2026-80010
• Device Sequence Number: 5141704
• Product Code: DZE
• UDI-Device Identifier: 07899995273574
• UDI-Public: 07899995273574
• 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): 06/19/2026

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: ILCM 3511
• Device Catalogue Number: ILCM 3511
• Device Lot Number: Y020542676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown