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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. GM ZYGOMA-S IMPLANT 3.5X35; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. GM ZYGOMA-S IMPLANT 3.5X35; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.1087
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/23/2026
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2025 in ada 16.On (b)(6) 2026, loss of osseointegration 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
GM ZYGOMA-S IMPLANT 3.5X35
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 Key25655113
Report Number0001222315-2026-001968
Device Sequence Number5902991
Product Code DZE
UDI-Device Identifier07899878059639
UDI-Public07899878059639
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
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) 06/29/2026
Report Date (Section F) 06/05/2026
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 Number109.1087
Device Lot NumberNPGJ9
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2026
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/29/2026
Device Age11 MO
Event Location Other
Date Report to Manufacturer06/05/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/29/2026
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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