Device product
LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Used in spinal fixation surgery.
Z-0421-2023
Product summary
- Event
- Event 91071
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 screws
- Official record key
device-enforcement:Z-0421-2023
Official wording
Reason: Potential for intraoperative screw head separation at weld location.
Code information: Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067
Distribution pattern: US distribution to California, Indiana, New York, Oklahoma, Washington DC
Derived failure modes
-
Unknown
Potential for intraoperative screw head separation at weld location.