Device product
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - 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-1221-2021
Product summary
- Event
- Event 87251
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1221-2021
Official wording
Reason: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Code information: Batch Number: 333017 333018 338838 346883 346884 351525 354404 358458 359841 364531 369361 370402 377835 377836 379927
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision