MAUDE Adverse Event Report: JJGC S.A. GM HELIX IMPLANT 7.0X11.5; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.1061
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports that the day the implant was placed in ada 14, failure occurred upon insertion.Details of surgery: primary stability not achieved, implant surface not completely covered with bone and immediate extraction site.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.
Event or Problem Description
The clinician reports that the day the implant was placed in ada 14, failure occurred upon insertion.Details of surgery: primary stability not achieved, implant surface not completely covered with bone, sinus augmentation and immediate extraction site.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.
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.

• Brand Name: GM HELIX IMPLANT 7.0X11.5
• 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: 12874739
• Report Number: 0001222315-2021-20630
• Device Sequence Number: 14612320
• Product Code: DZE
• UDI-Device Identifier: 07899878044499
• UDI-Public: 07899878044499
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K201225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022
• Report Date (Section F): 11/01/2021

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: 07/13/2025
• Device Model Number: 109.1061
• Device Catalogue Number: 109.1061
• Device Lot Number: CGN79
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2022
• Device Age: 15 MO
• Event Location: Other
• Date Report to Manufacturer: 11/01/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/25/2021
• Supplement Report FDA Received Date: 06/23/2022
• 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: 85 YR
• Patient Sex: Male