Insignia 336-0360Recalls & reported problems
Alphatec Spine, Inc. · Insignia, ACP, 3 Level, 60mm · Class 2 · Implant
All models of Insignia (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376423661), received between Sep 28, 2023 and Sep 28, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A MALE PATIENT UNDERWENT A 3-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON (B)(6) 2022. ONE YEAR POSTOPERATIVELY, RADIOGRAPH IMAGES REVEALED PSEUDARTHROSIS WITH GRAFT SUBSIDENCE. AT THE MOST INFERIOR LEVEL OF THE PLATE, A SCREW HAS STARTED TO BACKOUT. THERE IS A VISIBLE LOOSE RADIOPAQUE PIECE ANTERIOR TO THE SCREW BACKING OUT. IT IS UNKNOWN IF THE RADIOPAQUE PIECE IS PART OF THE BLOCKER THAT DETACHED FROM THE CONSTRUCT. REVISION SURGERY IS PLANNED.
Patient problems: Failure of Implant
MAUDE report 17830849 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
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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