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This device is manufactured by MEDTRONIC SOFAMOR DANEK USA.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Break | 4 | Device |
| 2017 | Use of Device Problem | 1 | Device |
| 2017 | Naturally Worn | 1 | Device |
| 2017 | Break | 20 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Loose or Intermittent Connection | 2 | Device |
| 2016 | Break | 22 | Device |
| 2015 | Use of Device Problem | 1 | Device |
| 2015 | Material Twisted/Bent | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 1 | Device |
| 2015 | Crack | 1 | Device |
| 2015 | Break | 14 | Device |
| 2014 | Use of Device Problem | 3 | Device |
| 2014 | Sticking | 2 | Device |
| 2014 | Device Inoperable | 1 | Device |
| 2014 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2014 | Detachment Of Device Component | 7 | Device |
| 2014 | Crack | 2 | Device |
| 2014 | Break | 76 | Device |
| 2014 | Bent | 3 | Device |
| 2013 | Device Damaged by Another Device | 1 | Device |
| 2013 | Break | 21 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |