Device product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - 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-1237-2021
Product summary
- Event
- Event 87251
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1237-2021
Official wording
Reason: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Code information: Batch Number: 345228 352383 357124 364542 370440 382120
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision