Device product
DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.
Z-0709-2013
Product summary
- Event
- Event 63665
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34 uits
- Official record key
device-enforcement:Z-0709-2013
Official wording
Reason: Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Code information: All lots
Distribution pattern: Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.
Derived failure modes
-
Unknown
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head