INVICTUS SPINAL FIXATION SYSTEM
Received Jul 14, 2026 · Event occurred Jun 24, 2026
Report 2027467-2026-00153 · MDR key 25813997
Device
Generic name
Screwdriver
Manufacturer
Alphatec Spine, Inc.Model number
17950-225Catalog number
17950-225
Lot number
EM49771
Product problems
- Break
- Material Separation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
VISUAL INSPECTION CONFIRMS THE EVENT. THE DISTAL TIP HAS SHEARED OFF AT THE BASE OF THE HEXALOBE. THIS FAILURE IS LIKELY DUE TO THE APPLIED TORSIONAL FORCE BEING GREATER THAN THE YIELD STRENGTH OF THE DEVICE. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE DRIVER BROKE DURING CLEANING AFTER A CASE.