Device product
3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Z-0921-2013
Product summary
- Event
- Event 64421
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 cervical screws
- Official record key
device-enforcement:Z-0921-2013
Official wording
Reason: Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
Code information: Part Number: GCSF37512 and Lot Number: 0243
Distribution pattern: USA Nationwide Distribution including the states of: CA and TX.
Derived failure modes
-
Unknown
Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.