MAUDE Adverse Event Report: JJGC S.A. GM HELIX IMPLANT 7.0X10; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.1060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Non-fatal serious injury or device malfunction stored due to covid 19 pandemic in accordance with fda guidance "postmarketing adverse event reporting for medical products and dietary supplements during a pandemic" published may 2020.
Event or Problem Description
The clinician reports that the day the implant was placed in ada 18, failure occurred upon insertion.Details of surgery: primary stability not achieved and implant surface not completely covered with bone.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.

• Brand Name: GM HELIX IMPLANT 7.0X10
• 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: 23666372
• Report Number: 0001222315-2025-003379
• Device Sequence Number: 21401491
• Product Code: DZE
• UDI-Device Identifier: 07899878044482
• UDI-Public: 07899878044482
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/27/2025
• Report Date (Section F): 03/14/2025

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: 109.1060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/27/2025
• Event Location: Other
• Date Report to Manufacturer: 03/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2025
• 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: 31 YR
• Patient Sex: Male