Device product
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft material out of the Graft Tube and adjacent to where the implant is to be placed, as supported within the Surgical Technique Guide.
Z-0117-2025
Product summary
- Firm
- Spineology, Inc.
- Event
- Event 95341
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 190 units
- Official record key
device-enforcement:Z-0117-2025
Official wording
Reason: Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
Code information: UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
Distribution pattern: Pending
Derived failure modes
-
Unknown
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.