CERTAIN GOLD-TITE HEXED SCREW

ABUTMENT SCREW

This device is manufactured by BIOMET 3I, ZIMMER DENTAL.

The following problems were reported about this device:

Year Description Events/year Type
2024 Unintended Movement 4 Device
2024 Fracture 15 Device
2023 Unintended Movement 4 Device
2023 Fracture 12 Device
2022 Unintended Movement 4 Device
2022 Fracture 4 Device
2021 Unintended Movement 2 Device
2021 Fracture 1 Device
2019 Unintended Movement 45 Device
2019 Separation Failure 2 Device
2019 Migration or Expulsion of Device 7 Device
2019 Mechanical Problem 1 Device
2019 Loosening of Implant Not Related to Bone-Ingrowth 1 Device
2019 Fracture 85 Device
2018 Unintended Movement 10 Device
2018 Separation Failure 6 Device
2018 Migration or Expulsion of Device 64 Device
2018 Mechanical Problem 7 Device
2018 Fracture 120 Device
2017 Separation Failure 1 Device
2017 Product Quality Problem 2 Device
2017 Migration or Expulsion of Device 19 Device
2017 Mechanical Problem 48 Device
2017 Fracture 58 Device
2017 Break 1 Device
2016 Product Quality Problem 1 Device
2016 Migration or Expulsion of Device 5 Device
2016 Mechanical Problem 3 Device
2016 Loose or Intermittent Connection 3 Device
2016 Fracture 41 Device
2016 Difficult to Remove 2 Device
2016 Detachment of Device or Device Component 1 Device
2016 Component Falling 1 Device
2016 Break 3 Device
2015 Fracture 13 Device
2015 Difficult to Remove 1 Device
2015 Break 1 Device
2014 Loose or Intermittent Connection 1 Device
2014 Fracture 1 Device