Device product
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
Z-1212-2021
Product summary
- Event
- Event 87251
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1212-2021
Official wording
Reason: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Code information: Batch Number: 330512 330513 338827 340984 344095 350509 350510 352675 361797 364055 364747 367798 370387 372182 377185 378428
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision