Device product
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumber vertebrae with a posterior approach.
Z-0177-2018
Product summary
- Event
- Event 78443
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-0177-2018
Official wording
Reason: A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.
Code information: Serial #'s; SP14003 and SP14005
Distribution pattern: Worldwide Distribution including France and Germany
Derived failure modes
-
Unknown
A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.