Insignia 236-1-24022Recalls & reported problems
Alphatec Spine, Inc. · 4.0mm Variable Angle, Self-Drilling Screw, Single Lead 22mm · Class 2 · Implant
All models of Insignia (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190376329970), received between Apr 2, 2026 and Apr 2, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Fracture
A PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON (B)(6) 2025. ABOUT 4 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED THAT TWO SCREWS HAD FRACTURED. THIS IS REPORT 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 24769109 ↗MalfunctionApr 2, 2026Fracture
A PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON (B)(6) 2025. ABOUT 4 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED THAT TWO SCREWS HAD FRACTURED. THIS IS REPORT 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 24769080 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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