MAUDE Adverse Event Report: JJGC S.A. GmHelixImplant,Ti,6.0X10mm; Endosseous Dental Implant

Catalog Number	109.1010
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Fibrosis (3167)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2024 in ada 19.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: infection, pain, mobility, bleeding and inflammation.No further patient complications were reported.

• Brand Name: GmHelixImplant,Ti,6.0X10mm
• 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: 50757900
• Report Number: 0001222315-2026-002831
• Device Sequence Number: 21249687
• Product Code: DZE
• UDI-Device Identifier: 07899878028727
• UDI-Public: 07899878028727
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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 Expiration Date: 01/26/2026
• Device Catalogue Number: 109.1010
• Device Lot Number: EYA22
• 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: 64 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: 70 YR
• Patient Sex: Male