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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.I.N. IMPLANT SYSTEM S.I.N. IMPLANT SYSTEM; DENTAL IMPLANT
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S.I.N. IMPLANT SYSTEM S.I.N. IMPLANT SYSTEM; DENTAL IMPLANT Back to Search Results
Model Number UCM 4310N
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 10/09/2024
Type of Reportable Event Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
 
Additional Manufacturer Narrative
Record was failed during initial submission.Resubmission to attempt to pass.Record failed indicated f5 had incorrect country code with value of telephone number.Problem is that f3 is the country code field.F5 is the telephone number field.F5 contains a telephone number has been listed.
 
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Brand Name
S.I.N. IMPLANT SYSTEM
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
S.I.N. IMPLANT SYSTEM
r. soldado ocimar guimaraes
da silva, 421, vila ro branco
sao paulo 03348 -060
BR  03348-060
MDR Report Key25449840
Report Number1060818-2026-80009
Device Sequence Number5840288
Product Code DZE
UDI-Device Identifier07899995215710
UDI-Public07899995215710
Combination Product (Y/N)N
Initial Reporter CountryCI
Number of Events Summarized1
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) 11/08/2024
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 Expiration Date10/28/2025
Device Model NumberUCM 4310N
Device Catalogue NumberUCM 4310N
Device Lot NumberU100345672
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date02/02/2026
Event Location Other
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/09/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device A
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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