MAUDE Adverse Event Report: JJGC S.A. GM HELIX IMPLANT 7.0X13; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.1062
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994); Fibrosis (3167)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2023 in ada 14.Details of surgery: implant surface not completely covered with bone, ridge augmentation and immediate extraction site.On (b)(6) 2023, non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: pain, mobility, bleeding and inflammation.No further patient complications were reported.

• Brand Name: GM HELIX IMPLANT 7.0X13
• 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: 16920933
• Report Number: 0001222315-2023-011720
• Device Sequence Number: 17872921
• Product Code: DZE
• UDI-Device Identifier: 07899878044505
• UDI-Public: 07899878044505
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/12/2023
• Report Date (Section F): 04/18/2023

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 Model Number: 109.1062
• Device Catalogue Number: 109.1062
• Device Lot Number: JHF17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/12/2023
• Device Age: 12 MO
• Event Location: Other
• Date Report to Manufacturer: 04/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2023
• 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: 39 YR
• Patient Sex: Female