Insignia 436-0238Recalls & reported problems
Alphatec Spine, Inc. · Insignia 2-Level ACP, 38mm · Class 2 · Implant
All models of Insignia (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00190376491073), received between Mar 26, 2024 and Sep 18, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Dislocated4
- Break1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Failure of Implant2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829814 ↗MalfunctionMay 5, 2026Device Dislodged or Dislocated
THE PATIENT UNDERWENT ACDFSPINAL PROCEDURE AT THE C6-7 LEVEL IN (B)(6) 2024. AROUND 12-MONTHS POSTOPERATIVELY, RADIOGRAPH IMAGING REVEALED A SCREW BACK OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085865 ↗MalfunctionJul 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SPINAL PROCEDURE AT LEVELS C4-C6 ON (B)(6) 2024. ABOUT 6 MONTHS POSTOPERATIVELY, A RADIOGRAPHIC IMAGE REVEALED THE SCREW AT C6 WAS BACKING OUT OF THE BOTTOM OF THE CONSTRUCT. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22645663 ↗InjuryMay 7, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SPINAL PROCEDURE IN (B)(6) 2024. IT WAS REPORTED THAT THE LOCKING MECHANISM FAILED, AND THE SCREW BACKED OUT POSTOPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 21977652 ↗MalfunctionMar 26, 2024Material Separation; Material Separation
ON (B)(6) 2024, A PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. IT WAS REPORTED ONE OF THE LOCKING MECHANISMS SEPARATED FROM THE PLATE POSTOPERATIVELY. THERE ARE NO PLANS FOR REVISION SURGERY. THE PATIENT IS ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18983076 ↗
Other Appliance, fixation, spinal intervertebral body devices
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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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