Invictus 55405-090-090Recalls & reported problems
Alphatec Spine, Inc. · SI.Core Fenestrated Favored Angle Screw, 9.0mm X 90mm · Class 2 · Implant
All models of Invictus (96)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376452319), received between May 16, 2025 and May 28, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture1
- Material Separation1
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2025Break; Break
IT WAS REPORTED THAT THE SCREW BROKE OFF AT THE NECK POSTOPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 22100757 ↗InjuryMay 16, 2025Break; Material Separation; Break; Material Separation
DURING A POSTOPERATIVE VISIT, A RADIOGRAPH IMAGE REVEALED A SCREW FRACTURE. THE PATIENT IS EXPERIENCING BACK PAIN AND UNDERWENT REVISION SURGERY TO REMOVE THE HARDWARE. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 22040073 ↗InjuryMay 16, 2025Fracture; Fracture
DURING A POSTOPERATIVE VISIT, A RADIOGRAPH IMAGE REVEALED A SCREW FRACTURE. THE PATIENT IS EXPERIENCING BACK PAIN AND UNDERWENT REVISION SURGERY TO REMOVE THE HARDWARE. THIS IS REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 22040058 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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