MAUDE Adverse Event Report: JJGC S.A. Gm Helix Lg Implant, Ti, 3.75x20; Endosseous Dental Implant

Catalog Number	109.1043
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fibrosis (3167); Hyperresponsive to stimuli (4538)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2025 in ada 4.Details of surgery: primary stability not achieved.On (b)(6) 2026, loss of osseointegration was verified.Patient presented with fair oral hygiene.The device was forwarded to the manufacturer.At the event the patient experienced: mobility and increased sensitivity.No further patient complications were reported.

• Brand Name: Gm Helix Lg Implant, Ti, 3.75x20
• 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 Key: 50197201
• Report Number: 0001222315-2026-002410
• Device Sequence Number: 10366019
• Product Code: DZE
• UDI-Device Identifier: 07899878031871
• UDI-Public: 07899878031871
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/10/2026
• Report Date (Section F): 08/10/2026

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 Number: 109.1043
• Device Lot Number: GETA6
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2026
• Device Age: 20 MO
• Event Location: Other
• Date Report to Manufacturer: 07/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2026
• 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 Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male