Device product
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - 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-1224-2021
Product summary
- Event
- Event 87251
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1224-2021
Official wording
Reason: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Code information: Batch Number: 333150 338842 341492 347125 351529 351530 358480 359845 364533 367814 369363 370406 377839 380043 380044 381527 381528 382443 382444 382445
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision