Invictus Spinal Fixation System
Received Jul 27, 2026 · Event occurred Jun 30, 2026
Report 2027467-2026-00162 · MDR key 50008555
Device
Generic name
Screwdriver
Manufacturer
Alphatec Spine, Inc.Model number
17111Catalog number
17111
Lot number
TI00031
Product problems
- Break
- Material Separation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the tip of the driver broke off during a case. The tip was retrieved.
Additional Manufacturer Narrative
Visual inspection confirms that the distal tip of driver has sheared off, along with a portion of the distal shaft. The failure is likely due to input torque exceeding the strength of the tip. Review of device history records showed no manufacturing or processing related irregularities. Labeling review:WARNINGS/CAUTIONS/PRECAUTIONS: Risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury. POSSIBLE ADVERSE EFFECTS: Initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.