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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. TAPERED IMPLANT IF 3.75X13 SP; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. TAPERED IMPLANT IF 3.75X13 SP; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number CD0902010
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/09/2026
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2022 in ada 19.On (b)(6) 2026, fracture of the implant was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.
 
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Brand Name
TAPERED IMPLANT IF 3.75X13 SP
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
JJGC S.A.
av. juscelino kubitschek de
oliveira, 3291 cic
curitiba PR 81270 -200
BR  81270-200
MDR Report Key24294279
Report Number0001222315-2026-000365
Device Sequence Number9397741
Product Code DZE
UDI-Device Identifier07899878038290
UDI-Public07899878038290
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2022
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/09/2026
Report Date (Section F) 01/16/2026
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 Catalogue NumberCD0902010
Device Lot NumberKMH21
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2026
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/09/2026
Device Age46 MO
Event Location Other
Date Report to Manufacturer01/16/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/09/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexMale
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