Invictus Spinal Fixation System
Received Jul 27, 2026 · Event occurred Jun 23, 2026
Report 2027467-2026-00150 · MDR key 50002121
Device
Generic name
Thoracolumbosacral Pedicle Screw System
Manufacturer
Alphatec Spine, Inc.Model number
55405-105-090Catalog number
55405-105-090
Product problems
- Fracture
Patient
Not reported
- Failure of Implant
- Insufficient Information
Narrative
Description of Event or Problem
It was reported that a screw fractured postoperatively.
Additional Manufacturer Narrative
The screw has not returned for evaluation. A radiographic image was provided which confirms the event. A review of the device history records could not be performed as the identifying lot number was not provided. Based on the information provided, the root cause could not be determined. Alphatec Spine is submitting this report to comply with the FDA regulations 21 CFR 803. Alphatec Spine has made reasonable efforts to provide as much relevant information as available. Any field that is left blank was not known at the time of this submission. If additional information is provided, a supplemental report will be submitted.