Device product
Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following indications: Degenerative Disk Disease, Trauma, Tumors, Deformities or curvatures, Psuedoarthrosis, Failed previous fusions, Spondylolistesis, and Spinal Stenosis.
Z-1989-2015
Product summary
- Event
- Event 71457
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 units
- Official record key
device-enforcement:Z-1989-2015
Official wording
Reason: Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation.
Code information: Lot numbers SM59161 and SM60278
Distribution pattern: US Nationwide Distribution in the states LA, TX, and PR.
Derived failure modes
-
Unknown
Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation.