MAUDE Adverse Event Report: JJGC S.A. GM HELIX ACQUA IMPLANT,TI,5.0X18; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.990
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2023 in ada 7.Details of surgery: primary stability not achieved and implant surface not completely covered with bone.On (b)(6) 2024, loss of osseointegration was verified.Patient presented with inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: pain.No further patient complications were reported.

• Brand Name: GM HELIX ACQUA IMPLANT,TI,5.0X18
• 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: 19022153
• Report Number: 0001222315-2024-000805
• Device Sequence Number: 18185747
• Product Code: DZE
• UDI-Device Identifier: 07899878025351
• UDI-Public: 07899878025351
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/02/2024
• Report Date (Section F): 03/05/2024

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: 01/10/2025
• Device Catalogue Number: 140.990
• Device Lot Number: EWA52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/02/2024
• Device Age: 49 MO
• Event Location: Other
• Date Report to Manufacturer: 03/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• 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: 79 YR
• Patient Sex: Male