GM HELIX IMPLANT,TI,4.0X10

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 73 Patient
2024 Swelling/ Edema 15 Patient
2024 Pain 68 Patient
2024 Inflammation 28 Patient
2024 Increased Sensitivity 2 Patient
2024 Hypersensitivity/Allergic reaction 1 Patient
2024 Hemorrhage/Blood Loss/Bleeding 16 Patient
2024 Fistula 5 Patient
2024 Fibrosis 67 Patient
2024 Abscess 7 Patient
2024 Separation Failure 1 Device
2024 Loss of Osseointegration 24 Device
2024 Fracture 1 Device
2024 Failure to Osseointegrate 247 Device
2024 Adverse Event Without Identified Device or Use Problem 15 Device
2023 Unspecified Infection 72 Patient
2023 Swelling/ Edema 14 Patient
2023 Sinus Perforation 1 Patient
2023 Pain 62 Patient
2023 Numbness 3 Patient
2023 Inflammation 19 Patient
2023 Increased Sensitivity 4 Patient
2023 Hypersensitivity/Allergic reaction 5 Patient
2023 Hemorrhage/Blood Loss/Bleeding 17 Patient
2023 Fistula 10 Patient
2023 Fibrosis 91 Patient
2023 Abscess 6 Patient
2023 Separation Failure 1 Device
2023 Loss of Osseointegration 39 Device
2023 Fracture 1 Device
2023 Failure to Osseointegrate 277 Device
2023 Difficult to Insert 2 Device
2023 Adverse Event Without Identified Device or Use Problem 18 Device
2022 Unspecified Infection 12 Patient
2022 Swelling/ Edema 3 Patient
2022 Pain 12 Patient
2022 Numbness 1 Patient
2022 Inflammation 3 Patient
2022 Increased Sensitivity 1 Patient
2022 Hemorrhage/Blood Loss/Bleeding 4 Patient
2022 Fistula 1 Patient
2022 Fibrosis 16 Patient
2022 Separation Failure 1 Device
2022 Loss of Osseointegration 23 Device
2022 Failure to Osseointegrate 172 Device
2022 Difficult to Insert 6 Device
2022 Adverse Event Without Identified Device or Use Problem 5 Device
2021 Loss of Osseointegration 4 Device
2021 Failure to Osseointegrate 18 Device
2020 Failure to Osseointegrate 1 Device
2019 Failure to Osseointegrate 6 Device