DENTAL IMPLANT
This device is manufactured by IMPLANT DIRECT SYBRON MANUFACTURING.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2021 | Osseointegration Problem | 1 | Device |
| 2020 | Positioning Problem | 2 | Device |
| 2020 | Osseointegration Problem | 6 | Device |
| 2020 | Loss of Osseointegration | 1 | Device |
| 2020 | Failure to Osseointegrate | 10 | Device |
| 2019 | Separation Failure | 10 | Device |
| 2019 | Positioning Problem | 53 | Device |
| 2019 | Positioning Failure | 3 | Device |
| 2019 | Patient Device Interaction Problem | 7 | Device |
| 2019 | Osseointegration Problem | 38 | Device |
| 2019 | Mechanical Problem | 1 | Device |
| 2019 | Material Deformation | 3 | Device |
| 2019 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2019 | Loss of Osseointegration | 51 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Inadequacy of Device Shape and/or Size | 6 | Device |
| 2019 | Fracture | 11 | Device |
| 2019 | Failure to Osseointegrate | 388 | Device |
| 2019 | Difficult to Open or Remove Packaging Material | 1 | Device |
| 2019 | Device Difficult to Setup or Prepare | 1 | Device |
| 2019 | Device Appears to Trigger Rejection | 1 | Device |
| 2019 | Detachment of Device or Device Component | 1 | Device |
| 2019 | Dent in Material | 1 | Device |
| 2019 | Break | 2 | Device |
| 2019 | Biocompatibility | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 14 | Device |
| 2018 | Separation Problem | 1 | Device |
| 2018 | Separation Failure | 9 | Device |
| 2018 | Scratched Material | 2 | Device |
| 2018 | Positioning Problem | 11 | Device |
| 2018 | Patient Device Interaction Problem | 3 | Device |
| 2018 | Osseointegration Problem | 4 | Device |
| 2018 | No Apparent Adverse Event | 1 | Device |
| 2018 | Material Deformation | 1 | Device |
| 2018 | Loss of Osseointegration | 20 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 2 | Device |
| 2018 | Fracture | 9 | Device |
| 2018 | Failure to Osseointegrate | 93 | Device |
| 2018 | Device-Device Incompatibility | 1 | Device |
| 2018 | Device Appears to Trigger Rejection | 26 | Device |
| 2018 | Deformation Due to Compressive Stress | 1 | Device |
| 2018 | Connection Problem | 3 | Device |
| 2018 | Break | 3 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2017 | Positioning Problem | 3 | Device |
| 2017 | Malposition of Device | 1 | Device |
| 2017 | Loss of Osseointegration | 4 | Device |
| 2017 | Fracture | 1 | Device |
| 2017 | Failure to Osseointegrate | 22 | Device |
| 2017 | Device-Device Incompatibility | 2 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Loss of Osseointegration | 2 | Device |
| 2016 | Insufficient Information | 1 | Device |
| 2016 | Fracture | 1 | Device |
| 2016 | Failure to Osseointegrate | 7 | Device |
| 2015 | Failure to Osseointegrate | 6 | Device |
| 2014 | Failure to Osseointegrate | 1 | Device |
| 2013 | Failure to Osseointegrate | 1 | Device |