REPLACE SELECT TAPERED TIU NP 3.5X10MM

ENDOSSEOUS DENTAL IMPLANT

This device is manufactured by NOBEL BIOCARE USA.

The following problems were reported about this device:

Year	Description	Events/year	Type
2024	Unspecified Infection	6	Patient
2024	Pain	21	Patient
2024	Numbness	3	Patient
2024	Foreign Body In Patient	3	Patient
2024	Fistula	1	Patient
2024	Failure of Implant	128	Patient
2024	Premature Separation	2	Device
2024	Migration	1	Device
2024	Loss of Osseointegration	38	Device
2024	Failure to Osseointegrate	52	Device
2024	Adverse Event Without Identified Device or Use Problem	1	Device
2023	Unspecified Infection	5	Patient
2023	Pain	11	Patient
2023	Osteomyelitis	2	Patient
2023	Numbness	8	Patient
2023	Fistula	3	Patient
2023	Failure of Implant	186	Patient
2023	Patient Device Interaction Problem	2	Device
2023	Osseointegration Problem	1	Device
2023	Material Deformation	1	Device
2023	Loss of Osseointegration	66	Device
2023	Fracture	2	Device
2023	Failure to Osseointegrate	96	Device
2023	Adverse Event Without Identified Device or Use Problem	9	Device
2023	Activation, Positioning or Separation Problem	1	Device
2022	Unspecified Infection	3	Patient
2022	Pain	2	Patient
2022	Numbness	4	Patient
2022	Inflammation	2	Patient
2022	Failure of Implant	39	Patient
2022	Osseointegration Problem	8	Device
2022	Loss of Osseointegration	38	Device
2022	Fracture	9	Device
2022	Failure to Osseointegrate	95	Device
2022	Adverse Event Without Identified Device or Use Problem	1	Device
2021	Unspecified Infection	2	Patient
2021	Pain	4	Patient
2021	Failure of Implant	6	Patient
2021	Loss of Osseointegration	6	Device
2021	Failure to Osseointegrate	25	Device
2020	Failure of Implant	11	Patient
2020	Loss of Osseointegration	4	Device
2020	Failure to Osseointegrate	20	Device
2019	Failure of Implant	2	Patient
2019	Osseointegration Problem	8	Device
2019	Loss of Osseointegration	79	Device
2019	Fracture	6	Device
2019	Failure to Osseointegrate	94	Device
2019	Adverse Event Without Identified Device or Use Problem	2	Device
2018	Failure of Implant	5	Patient
2018	Abscess	2	Patient
2018	Separation Failure	1	Device
2018	Material Deformation	1	Device
2018	Malposition of Device	1	Device
2018	Loss of Osseointegration	17	Device
2018	Fracture	4	Device
2018	Failure to Osseointegrate	53	Device
2018	Device Damaged by Another Device	1	Device
2018	Adverse Event Without Identified Device or Use Problem	3	Device
2017	Failure of Implant	2	Patient
2017	Loss of Osseointegration	6	Device
2017	Failure to Osseointegrate	4	Device
2016	Loss of Osseointegration	1	Device
2016	Failure to Osseointegrate	3	Device
2015	Pain	1	Patient
2015	Failure of Implant	3	Patient
2015	Loss of Osseointegration	1	Device
2015	Failure to Osseointegrate	4	Device
2014	Failure to Osseointegrate	2	Device
2013	Failure of Implant	2	Patient
2013	Failure to Osseointegrate	4	Device
2011	Failure of Implant	2	Patient
2011	Failure to Osseointegrate	2	Device
2010	Failure of Implant	2	Patient
2010	Failure to Osseointegrate	4	Device
2009	Failure of Implant	4	Patient
2009	Failure to Osseointegrate	4	Device
2008	Failure of Implant	2	Patient
2008	Failure to Osseointegrate	2	Device