Insignia 436-0470Recalls & reported problems
Alphatec Spine, Inc. · Insignia 4-Level ACP, 70mm · 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 00190376491356), received between Nov 25, 2025 and May 27, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Fracture1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON (B)(6) 2025. ABOUT 1 YEAR POSTOPERATIVELY, A RADIOGRAPHIC IMAGE REVEALED A SCREW BACKOUT AT THE MOST INFERIOR LEVEL. THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310601 ↗MalfunctionNov 25, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
A PATIENT UNDERWENT A 4-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON (B)(6) 2024. AROUND ONE YEAR POSTOPERATIVELY, A RADIOGRAPHIC IMAGE REVEALED THAT THE LOCKING MECHANISM HAD BROKEN OFF, CAUSING THE SCREW TO BACKOUT AND FRACTURE. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 23647399 ↗
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- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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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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