CETRA 19-0236Recalls & reported problems
Orthofix US LLC · 2-LEVEL PLATE ASSEMBLY, 36MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 18257200120406), received between Dec 3, 2025 and Jul 27, 2026 — classified as 1 injury, 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
- Unintended Movement2
- Break1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information3
- Intervertebral Disc Compression or Protrusion1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Insufficient Device Problem Information
It was reported a patient with new herniated nucleus pulpous (HNP) at C6/7 (below fusion) after a fall-- with cord compression.
Patient problems: Intervertebral Disc Compression or Protrusion
MAUDE report 50015873 ↗MalfunctionDec 3, 2025Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement
IT WAS REPORTED THAT A PATIENT RECEIVED A 36MM CETRA PLATE WITH TWO TI CAGES IN (B)(6) 2025. AT A FOLLOW UP VISIT THE PHYSICIAN NOTICED TWO INFERIOR SCREWS HAD BACKED OUT. THE PATIENT SUBSEQUENTLY UNDERWENT A REVISION OF THE ACDF ON (B)(6) 2025. DURING THE REVISION IT WAS OBSERVED THE LOCKING PLATE HAS BROKEN OFF OF THE PLATE. THE PHYSICIAN REMOVED THE ENTIRE CONSRTUCT AND REVISED COMPLETELY.
Patient problems: Insufficient Information
MAUDE report 23707985 ↗MalfunctionDec 3, 2025Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement
IT WAS REPORTED THAT A PATIENT RECEIVED A 36MM CETRA PLATE WITH TWO TI CAGES IN (B)(6) 2025. AT A FOLLOW UP VISIT THE PHYSICIAN NOTICED TWO INFERIOR SCREWS HAD BACKED OUT. THE PATIENT SUBSEQUENTLY UNDERWENT A REVISION OF THE ACDF (B)(6) 2025. DURING THE REVISION IT WAS OBSERVED THE LOCKING PLATE HAS BROKEN OFF OF THE PLATE. THE PHYSICIAN REMOVED THE ENTIRE CONSTRUCT AND REVISED COMPLETELY.
Patient problems: Insufficient Information
MAUDE report 23707896 ↗MalfunctionDec 3, 2025Break; Break
IT WAS REPORTED THAT A PATIENT RECEIVED A 36MM CETRA PLATE WITH TWO TI CAGES IN (B)(6) 2025. AT A FOLLOW UP VISIT THE PHYSICIAN NOTICED TWO INFERIOR SCREWS HAD BACKED OUT. THE PATIENT SUBSEQUENTLY UNDERWENT A REVISION OF THE ACDF ON (B)(6) 2025. DURING THE REVISION IT WAS OBSERVED THE LOCKING PLATE HAS BROKEN OFF OF THE PLATE. THE PHYSICIAN REMOVED THE ENTIRE CONSRTUCT AND REVISED COMPLETELY.
Patient problems: Insufficient Information
MAUDE report 23707312 ↗
Other Appliance, fixation, spinal intervertebral body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- 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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