GM HELIX ACQUA IMPLANT,TI,3.5X13

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 73 Patient
2024 Swelling/ Edema 12 Patient
2024 Sinus Perforation 5 Patient
2024 Pain 78 Patient
2024 Numbness 4 Patient
2024 Inflammation 32 Patient
2024 Increased Sensitivity 7 Patient
2024 Hypersensitivity/Allergic reaction 6 Patient
2024 Hemorrhage/Blood Loss/Bleeding 15 Patient
2024 Fistula 6 Patient
2024 Fibrosis 81 Patient
2024 Abscess 16 Patient
2024 Loss of Osseointegration 90 Device
2024 Fracture 8 Device
2024 Failure to Osseointegrate 174 Device
2024 Difficult to Insert 2 Device
2024 Adverse Event Without Identified Device or Use Problem 7 Device
2023 Unspecified Infection 26 Patient
2023 Swelling/ Edema 4 Patient
2023 Sinus Perforation 1 Patient
2023 Pain 61 Patient
2023 Inflammation 19 Patient
2023 Increased Sensitivity 11 Patient
2023 Hypersensitivity/Allergic reaction 6 Patient
2023 Hemorrhage/Blood Loss/Bleeding 11 Patient
2023 Fistula 5 Patient
2023 Fibrosis 80 Patient
2023 Abscess 3 Patient
2023 Loss of Osseointegration 74 Device
2023 Fracture 1 Device
2023 Failure to Osseointegrate 132 Device
2023 Difficult to Insert 3 Device
2023 Adverse Event Without Identified Device or Use Problem 11 Device
2022 Unspecified Infection 2 Patient
2022 Pain 6 Patient
2022 Inflammation 4 Patient
2022 Increased Sensitivity 2 Patient
2022 Hemorrhage/Blood Loss/Bleeding 2 Patient
2022 Fibrosis 15 Patient
2022 Loss of Osseointegration 78 Device
2022 Fracture 2 Device
2022 Failure to Osseointegrate 76 Device
2022 Difficult to Insert 3 Device
2022 Adverse Event Without Identified Device or Use Problem 10 Device
2021 Hypersensitivity/Allergic reaction 2 Patient
2021 Fibrosis 2 Patient
2021 Loss of Osseointegration 2 Device
2021 Failure to Osseointegrate 17 Device
2020 Failure to Osseointegrate 6 Device
2019 Loss of Osseointegration 5 Device
2019 Failure to Osseointegrate 21 Device
2019 Adverse Event Without Identified Device or Use Problem 3 Device
2018 Adverse Event Without Identified Device or Use Problem 1 Device