GM HELIX 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	31	Patient
2024	Swelling/ Edema	10	Patient
2024	Sinus Perforation	1	Patient
2024	Pain	37	Patient
2024	Numbness	1	Patient
2024	Inflammation	11	Patient
2024	Increased Sensitivity	7	Patient
2024	Hemorrhage/Blood Loss/Bleeding	4	Patient
2024	Fistula	5	Patient
2024	Fibrosis	48	Patient
2024	Abscess	2	Patient
2024	Loss of Osseointegration	18	Device
2024	Failure to Osseointegrate	141	Device
2024	Difficult to Insert	2	Device
2024	Adverse Event Without Identified Device or Use Problem	8	Device
2023	Unspecified Infection	35	Patient
2023	Swelling/ Edema	17	Patient
2023	Sinus Perforation	1	Patient
2023	Pain	69	Patient
2023	Numbness	4	Patient
2023	Inflammation	22	Patient
2023	Increased Sensitivity	8	Patient
2023	Hypersensitivity/Allergic reaction	1	Patient
2023	Hemorrhage/Blood Loss/Bleeding	12	Patient
2023	Fistula	19	Patient
2023	Fibrosis	69	Patient
2023	Abscess	8	Patient
2023	Loss of Osseointegration	44	Device
2023	Fracture	2	Device
2023	Failure to Osseointegrate	186	Device
2023	Difficult to Insert	1	Device
2023	Adverse Event Without Identified Device or Use Problem	7	Device
2022	Unspecified Infection	11	Patient
2022	Swelling/ Edema	5	Patient
2022	Pain	11	Patient
2022	Inflammation	7	Patient
2022	Hemorrhage/Blood Loss/Bleeding	2	Patient
2022	Fistula	1	Patient
2022	Fibrosis	9	Patient
2022	Loss of Osseointegration	25	Device
2022	Failure to Osseointegrate	162	Device
2022	Difficult to Insert	2	Device
2022	Adverse Event Without Identified Device or Use Problem	14	Device
2021	Fibrosis	2	Patient
2021	Loss of Osseointegration	10	Device
2021	Failure to Osseointegrate	34	Device
2020	Failure to Osseointegrate	4	Device
2019	Adverse Event Without Identified Device or Use Problem	1	Device