MAUDE Adverse Event Report: JJGC S.A. GM HELIX ACQUA IMPLANT 7.0x11.5; Endosseous Dental Implant

Catalog Number	140.1061
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Fibrosis (3167)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2025 in ada 30.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2026, loss of osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.

• Brand Name: GM HELIX ACQUA IMPLANT 7.0x11.5
• 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: 50757901
• Report Number: 0001222315-2026-002831
• Device Sequence Number: 9668159
• Product Code: DZE
• UDI-Device Identifier: 07899878044536
• UDI-Public: 07899878044536
• 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): 09/14/2026
• Report Date (Section F): 09/14/2026

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: 140.1061
• Device Lot Number: TMY11
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/14/2026
• Device Age: 51 MO
• Event Location: Other
• Date Report to Manufacturer: 08/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• 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: 60 YR
• Patient Sex: Male