Device product
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - 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-1223-2021
Product summary
- Event
- Event 87251
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1223-2021
Official wording
Reason: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Code information: Batch Number: 333021 333022 338840 341489 343445 346886 351527 351528 351528 351528 351528 351528 351528 358459 358459 358459 358459 358459 358459 362405 363444 364766 364766 369197 369197 370268 377838 377838 379930 379930 379930 379930 379931 379931 385407
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision