GM HELIX ACQUA IMPLANT,TI,3.5X11.5

ENDOSSEOUS DENTAL IMPLANT

This device is manufactured by INSTITUT STRAUMANN AG, NEODENT - JJGC SA.

The following problems were reported about this device:

Year Description Events/year Type
2024 Unspecified Infection 29 Patient
2024 Swelling/ Edema 1 Patient
2024 Sinus Perforation 1 Patient
2024 Pain 42 Patient
2024 Inflammation 11 Patient
2024 Increased Sensitivity 10 Patient
2024 Hypersensitivity/Allergic reaction 1 Patient
2024 Hemorrhage/Blood Loss/Bleeding 13 Patient
2024 Fistula 11 Patient
2024 Fibrosis 55 Patient
2024 Abscess 6 Patient
2024 Loss of Osseointegration 15 Device
2024 Failure to Osseointegrate 112 Device
2024 Adverse Event Without Identified Device or Use Problem 3 Device
2023 Unspecified Infection 32 Patient
2023 Swelling/ Edema 2 Patient
2023 Pain 47 Patient
2023 Inflammation 23 Patient
2023 Increased Sensitivity 12 Patient
2023 Hypersensitivity/Allergic reaction 2 Patient
2023 Hemorrhage/Blood Loss/Bleeding 18 Patient
2023 Fistula 4 Patient
2023 Fibrosis 77 Patient
2023 Abscess 2 Patient
2023 Separation Failure 4 Device
2023 Loss of Osseointegration 48 Device
2023 Fracture 5 Device
2023 Failure to Osseointegrate 133 Device
2023 Difficult to Insert 3 Device
2023 Adverse Event Without Identified Device or Use Problem 11 Device
2022 Unspecified Infection 2 Patient
2022 Swelling/ Edema 3 Patient
2022 Pain 15 Patient
2022 Inflammation 4 Patient
2022 Increased Sensitivity 4 Patient
2022 Hypersensitivity/Allergic reaction 2 Patient
2022 Fistula 1 Patient
2022 Fibrosis 18 Patient
2022 Loss of Osseointegration 57 Device
2022 Failure to Osseointegrate 119 Device
2022 Adverse Event Without Identified Device or Use Problem 7 Device
2021 Swelling/ Edema 2 Patient
2021 Loss of Osseointegration 6 Device
2021 Failure to Osseointegrate 19 Device
2021 Adverse Event Without Identified Device or Use Problem 3 Device
2020 Loss of Osseointegration 2 Device
2020 Failure to Osseointegrate 7 Device
2019 Loss of Osseointegration 1 Device
2019 Failure to Osseointegrate 7 Device
2019 Adverse Event Without Identified Device or Use Problem 4 Device
2018 Adverse Event Without Identified Device or Use Problem 1 Device