MAUDE Adverse Event Report: JJGC S.A. GM Helix Acqua Implant,Ti,4.0X18; Endosseous Dental Implant

Catalog Number	140.987
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Fibrosis (3167)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2026 in ada 2.Details of surgery: implant surface not completely covered with bone and immediate extraction site.On (b)(6) 2026, non-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,Ti,4.0X18
• 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: 50258362
• Report Number: 0001222315-2026-002468
• Device Sequence Number: 21394015
• Product Code: DZE
• UDI-Device Identifier: 07899878025320
• UDI-Public: 07899878025320
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 08/14/2026
• Report Date (Section F): 08/14/2026

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: 140.987
• Device Lot Number: YCXH5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2026
• Device Age: 16 MO
• Event Location: Other
• Date Report to Manufacturer: 07/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2026
• 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 Sex: Male