Device product
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.
Z-1797-2021
Product summary
- Event
- Event 87842
- Status
- Terminated
- Classification
- Class II
- Quantity
- 162 UNITS
- Official record key
device-enforcement:Z-1797-2021
Official wording
Reason: Product is impacted by a thread profile defect due to a manufacturing issue.
Code information: CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028
Distribution pattern: International distribution in the countries of France, Switzerland and Jordan. No US distribution.
Derived failure modes
-
Manufacturing or process control
defect due to a manufacturing