Device product
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
Z-0102-2018
Product summary
- Event
- Event 78372
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 (4 US and 17 OUS)
- Official record key
device-enforcement:Z-0102-2018
Official wording
Reason: An undetected shift between the information displayed in the navigation software and the actual patient anatomy
Code information: Serial #s; RO10009, RO10011, RO10014, and RO13023
Distribution pattern: OH, MI and TX
Derived failure modes
-
Unknown
An undetected shift between the information displayed in the navigation software and the actual patient anatomy