Insignia 436-0478Recalls & reported problems
Alphatec Spine, Inc. · Insignia 4-Level ACP, 78mm · Class 2 · Implant
All models of Insignia (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376491370), received between Jul 29, 2025 and May 11, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Dislocated3
Patient problems
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT A 4-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON (B)(6) 2025. ABOUT 3 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED A SCREW BACKOUT AT THE MOST INFERIOR LEVEL. THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 25137441 ↗InjuryJul 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SPINAL PROCEDURE AT LEVELS C3-C7 ON (B)(6) 2025. AT THE ONE-WEEK POSTOPERATIVE VISIT, A RADIOGRAPHIC IMAGE REVEALED AN INFERIOR SCREW WAS BACKING OUT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE AND REPLACE THE SCREW. APPROXIMATELY TWO MONTHS POSTOPERATIVELY OF THE REVISION SURGERY, RADIOGRAPHIC IMAGING AGAIN REVEALED AN INFERIOR SCREW WAS BACKING OUT OF THE PLATE. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE THE SCREW. THIS IS REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 22650516 ↗InjuryJul 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SPINAL PROCEDURE AT LEVELS C3-C7 ON (B)(6) 2025. AT THE ONE-WEEK POSTOPERATIVE VISIT, A RADIOGRAPHIC IMAGE REVEALED AN INFERIOR SCREW WAS BACKING OUT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE AND REPLACE THE SCREW. APPROXIMATELY TWO MONTHS POSTOPERATIVELY OF THE REVISION SURGERY, RADIOGRAPHIC IMAGING AGAIN REVEALED AN INFERIOR SCREW WAS BACKING OUT OF THE PLATE. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE THE SCREW. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 22650373 ↗
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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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