Insignia 436-0360Recalls & reported problems
Alphatec Spine, Inc. · Insignia 3-Level ACP, 60mm · Class 2 · Implant
All models of Insignia (34)
Data updated Oct 18, 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 00190376491257), received between Jun 19, 2025 and Mar 31, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated2
Patient problems
- Failure of Implant2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT A 3-LEVEL ANTERIOR CERVICAL AND DISCECTOMY FUSION PROCEDURE ON (B)(6) 2025. ABOUT 6 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED THAT TWO SUPERIOR SCREWS HAD FRACTURED, AND 1 INFERIOR SCREW HAD BEGUN TO BACKOUT OF THE PLATE. THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 3 OF 3.
Patient problems: Failure of Implant
MAUDE report 24746127 ↗MalfunctionJun 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SPINAL PROCEDURE ON (B)(6) 2025. ABOUT 3 MONTHS POSTOPERATIVELY, A RADIOGRAPH IMAGE REVEALED THE SCREW WAS STARTING TO BACKOUT OF THE PLATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 22293640 ↗
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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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