Insignia 336-0356Recalls & reported problems
Alphatec Spine, Inc. · Insignia, ACP, 3 Level, 56mm · Class 2 · Implant
All models of Insignia (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376423647), received between Nov 16, 2022 and Jun 23, 2026 — classified as 3 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
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2026Detachment of Device or Device Component
POSTOPERATIVE RADIOGRAPHIC IMAGING REVEALED A SCREW BACKING OUT OF THE PLATE. THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598653 ↗MalfunctionFeb 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED A POSTOPERATIVE RADIOGRAPH REVEALED A DISTAL SCREW BACKING OUT OF A 3-LEVEL INSIGNIA PLATE. NO REVISION SURGERY SCHEDULED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16375591 ↗MalfunctionNov 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2022, A PATIENT UNDERWENT A 3-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. AROUND 6 WEEKS POSTOPERATIVELY, A RADIOGRAPH IMAGE REVEALED ONE OF THE INFERIOR SCREWS HAD STARTED TO BACKOUT. THE SURGEON PLANS TO MONITOR THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 15809470 ↗
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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