CETRA 19-0354Recalls & reported problems
Orthofix US LLC · 3-LEVEL PLATE ASSEMBLY, 54MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18257200120536), received between Sep 30, 2022 and Jul 27, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Insufficient Device Problem Information1
- Material Separation1
Patient problems
- Insufficient Information1
- Neck Pain1
- 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.
InjuryJul 27, 2026Insufficient Device Problem Information
it was reported: Neck Pain: Incomplete healing of ACDF. Patient was treated with medication and supplemental fixation.
Patient problems: Neck Pain
MAUDE report 50015876 ↗MalfunctionJan 17, 2024Material Separation; Material Separation
INFORMATION PROVIDED STATES THAT PATIENT HAD ACDF (ANTERIOR CERVICAL DISCECTOMY FUSION) AT LEVELS C4-C7 IN (B)(6) 2023. PATIENT RETURNED FOR 6 WEEK FOLLOW AND IMAGES SHOWED THE INTERIOR LOCKING MECHANISM OF THE CETRA PLATE HAD FAILED. THE DEVICE WAS EXPLANTED ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531998 ↗MalfunctionSep 30, 2022Fracture; Fracture
INFORMATION PROVIDED STATES THAT THE LOCKING MECHANISM ON AN IMPLANTED CETRA 3-LEVEL CERVICAL PLATE FAILED AT LEVEL C6. THE PATIENT UNDERWENT A REVISION SURGERY WHERE A CORPECTOMY WAS REQUIRED.
Patient problems: Insufficient Information
MAUDE report 15513276 ↗
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- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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