GM HELIX IMPLANT,TI,3.75X10

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 27 Patient
2024 Swelling/ Edema 10 Patient
2024 Sinus Perforation 1 Patient
2024 Pain 35 Patient
2024 Inflammation 7 Patient
2024 Increased Sensitivity 4 Patient
2024 Fistula 4 Patient
2024 Fibrosis 33 Patient
2024 Abscess 2 Patient
2024 Loss of Osseointegration 12 Device
2024 Fracture 1 Device
2024 Failure to Osseointegrate 154 Device
2024 Difficult to Insert 2 Device
2024 Adverse Event Without Identified Device or Use Problem 6 Device
2023 Unspecified Infection 37 Patient
2023 Swelling/ Edema 8 Patient
2023 Sinus Perforation 1 Patient
2023 Pain 54 Patient
2023 Numbness 1 Patient
2023 Inflammation 11 Patient
2023 Increased Sensitivity 4 Patient
2023 Hypersensitivity/Allergic reaction 1 Patient
2023 Hemorrhage/Blood Loss/Bleeding 7 Patient
2023 Fistula 5 Patient
2023 Fibrosis 51 Patient
2023 Abscess 3 Patient
2023 Separation Failure 1 Device
2023 Loss of Osseointegration 19 Device
2023 Fracture 3 Device
2023 Failure to Osseointegrate 176 Device
2023 Adverse Event Without Identified Device or Use Problem 10 Device
2022 Unspecified Infection 7 Patient
2022 Swelling/ Edema 4 Patient
2022 Pain 16 Patient
2022 Inflammation 1 Patient
2022 Hemorrhage/Blood Loss/Bleeding 1 Patient
2022 Fistula 4 Patient
2022 Fibrosis 12 Patient
2022 Loss of Osseointegration 8 Device
2022 Failure to Osseointegrate 143 Device
2022 Adverse Event Without Identified Device or Use Problem 5 Device
2021 Hemorrhage/Blood Loss/Bleeding 1 Patient
2021 Loss of Osseointegration 2 Device
2021 Failure to Osseointegrate 26 Device
2021 Adverse Event Without Identified Device or Use Problem 2 Device
2020 Loss of Osseointegration 1 Device
2020 Failure to Osseointegrate 1 Device
2019 Failure to Osseointegrate 1 Device