GM HELIX IMPLANT,TI,4.3X10

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 122 Patient
2024 Swelling/ Edema 22 Patient
2024 Sinus Perforation 1 Patient
2024 Pain 101 Patient
2024 Inflammation 26 Patient
2024 Increased Sensitivity 10 Patient
2024 Hypersensitivity/Allergic reaction 4 Patient
2024 Hemorrhage/Blood Loss/Bleeding 29 Patient
2024 Fistula 21 Patient
2024 Fibrosis 120 Patient
2024 Abscess 12 Patient
2024 Separation Failure 1 Device
2024 Loss of Osseointegration 43 Device
2024 Fracture 2 Device
2024 Failure to Osseointegrate 292 Device
2024 Difficult to Insert 7 Device
2024 Adverse Event Without Identified Device or Use Problem 22 Device
2023 Unspecified Infection 50 Patient
2023 Swelling/ Edema 12 Patient
2023 Sinus Perforation 2 Patient
2023 Pain 67 Patient
2023 Inflammation 39 Patient
2023 Increased Sensitivity 2 Patient
2023 Hypersensitivity/Allergic reaction 1 Patient
2023 Hemorrhage/Blood Loss/Bleeding 14 Patient
2023 Fistula 8 Patient
2023 Fibrosis 79 Patient
2023 Abscess 11 Patient
2023 Loss of Osseointegration 26 Device
2023 Fracture 6 Device
2023 Failure to Osseointegrate 215 Device
2023 Difficult to Insert 1 Device
2023 Adverse Event Without Identified Device or Use Problem 11 Device
2022 Unspecified Infection 12 Patient
2022 Swelling/ Edema 2 Patient
2022 Sinus Perforation 4 Patient
2022 Pain 15 Patient
2022 Inflammation 8 Patient
2022 Hemorrhage/Blood Loss/Bleeding 5 Patient
2022 Fistula 2 Patient
2022 Fibrosis 33 Patient
2022 Abscess 1 Patient
2022 Separation Failure 1 Device
2022 Loss of Osseointegration 15 Device
2022 Failure to Osseointegrate 154 Device
2022 Difficult to Insert 3 Device
2022 Adverse Event Without Identified Device or Use Problem 8 Device
2021 Unspecified Infection 1 Patient
2021 Fibrosis 3 Patient
2021 Loss of Osseointegration 1 Device
2021 Failure to Osseointegrate 22 Device
2021 Adverse Event Without Identified Device or Use Problem 3 Device
2020 Failure to Osseointegrate 1 Device
2019 Failure to Osseointegrate 2 Device
2019 Adverse Event Without Identified Device or Use Problem 1 Device