GM HELIX IMPLANT,TI,4.0X11.5

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 60 Patient
2024 Swelling/ Edema 4 Patient
2024 Pain 36 Patient
2024 Inflammation 15 Patient
2024 Increased Sensitivity 4 Patient
2024 Hypersensitivity/Allergic reaction 5 Patient
2024 Hemorrhage/Blood Loss/Bleeding 14 Patient
2024 Fistula 5 Patient
2024 Fibrosis 44 Patient
2024 Abscess 1 Patient
2024 Loss of Osseointegration 18 Device
2024 Fracture 1 Device
2024 Failure to Osseointegrate 142 Device
2024 Difficult to Insert 8 Device
2024 Adverse Event Without Identified Device or Use Problem 5 Device
2023 Unspecified Infection 42 Patient
2023 Swelling/ Edema 7 Patient
2023 Sinus Perforation 3 Patient
2023 Pain 34 Patient
2023 Numbness 1 Patient
2023 Inflammation 9 Patient
2023 Increased Sensitivity 3 Patient
2023 Hemorrhage/Blood Loss/Bleeding 10 Patient
2023 Fistula 6 Patient
2023 Fibrosis 52 Patient
2023 Abscess 1 Patient
2023 Loss of Osseointegration 26 Device
2023 Fracture 1 Device
2023 Failure to Osseointegrate 158 Device
2023 Difficult to Insert 2 Device
2023 Adverse Event Without Identified Device or Use Problem 9 Device
2022 Unspecified Infection 14 Patient
2022 Swelling/ Edema 6 Patient
2022 Pain 16 Patient
2022 Inflammation 4 Patient
2022 Hemorrhage/Blood Loss/Bleeding 4 Patient
2022 Fistula 2 Patient
2022 Fibrosis 8 Patient
2022 Abscess 4 Patient
2022 Separation Failure 2 Device
2022 Loss of Osseointegration 25 Device
2022 Fracture 1 Device
2022 Failure to Osseointegrate 103 Device
2022 Difficult to Insert 5 Device
2022 Adverse Event Without Identified Device or Use Problem 5 Device
2021 Loss of Osseointegration 9 Device
2021 Failure to Osseointegrate 12 Device
2021 Adverse Event Without Identified Device or Use Problem 6 Device
2020 Failure to Osseointegrate 2 Device
2019 Failure to Osseointegrate 4 Device