Device product
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
Z-1976-2013
Product summary
- Firm
- Stryker Spine
- Event
- Event 65777
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1536 units (US) 880 (Foreign)
- Official record key
device-enforcement:Z-1976-2013
Official wording
Reason: Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Code information: K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.