Device product
MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons 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 lumbar vertebrae with a posterior approach.
Z-1755-2017
Product summary
- Event
- Event 76820
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1755-2017
Official wording
Reason: Unapproved change made by the supplier.
Code information: Serial #'s: SP16008
Distribution pattern: Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.
Derived failure modes
-
Unknown
Unapproved change made by the supplier.