GM HELIX IMPLANT,TI,3.75X11.5

ENDOSSEOUS DENTAL IMPLANT

This device is manufactured by NEODENT - JJGC SA.

The following problems were reported about this device:

Year Description Events/year Type
2024 Unspecified Infection 37 Patient
2024 Swelling/ Edema 4 Patient
2024 Sinus Perforation 1 Patient
2024 Pain 40 Patient
2024 Numbness 4 Patient
2024 Inflammation 9 Patient
2024 Increased Sensitivity 3 Patient
2024 Hypersensitivity/Allergic reaction 1 Patient
2024 Hemorrhage/Blood Loss/Bleeding 7 Patient
2024 Fistula 2 Patient
2024 Fibrosis 36 Patient
2024 Abscess 6 Patient
2024 Loss of Osseointegration 14 Device
2024 Failure to Osseointegrate 135 Device
2024 Difficult to Insert 4 Device
2024 Adverse Event Without Identified Device or Use Problem 10 Device
2023 Unspecified Infection 46 Patient
2023 Swelling/ Edema 15 Patient
2023 Pain 61 Patient
2023 Inflammation 17 Patient
2023 Increased Sensitivity 3 Patient
2023 Hypersensitivity/Allergic reaction 3 Patient
2023 Hemorrhage/Blood Loss/Bleeding 13 Patient
2023 Fistula 10 Patient
2023 Fibrosis 58 Patient
2023 Abscess 5 Patient
2023 Loss of Osseointegration 15 Device
2023 Fracture 2 Device
2023 Failure to Osseointegrate 181 Device
2023 Adverse Event Without Identified Device or Use Problem 10 Device
2022 Unspecified Infection 16 Patient
2022 Swelling/ Edema 4 Patient
2022 Pain 12 Patient
2022 Inflammation 7 Patient
2022 Increased Sensitivity 1 Patient
2022 Hemorrhage/Blood Loss/Bleeding 1 Patient
2022 Fistula 5 Patient
2022 Fibrosis 10 Patient
2022 Abscess 2 Patient
2022 Loss of Osseointegration 16 Device
2022 Fracture 1 Device
2022 Failure to Osseointegrate 117 Device
2022 Difficult to Insert 1 Device
2022 Adverse Event Without Identified Device or Use Problem 3 Device
2021 Fibrosis 1 Patient
2021 Loss of Osseointegration 2 Device
2021 Failure to Osseointegrate 33 Device
2021 Difficult to Insert 1 Device
2020 Unspecified Infection 1 Patient
2020 Fibrosis 1 Patient
2020 Failure to Osseointegrate 3 Device