CETRA 19-0358Recalls & reported problems
Orthofix US LLC · 3-LEVEL PLATE ASSEMBLY, 58MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18257200120550), received between Sep 20, 2024 and Sep 20, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS STATED THAT IN TWO SEPARATE EVENTS THE CETRA 3 LEVEL PLATES HAD THE LOCKING MECHANISM POP OFF AND THEREFORE THE SCREW BACKED OUT. IN BOTH SITUATIONS IT WAS A THREE LEVEL PLATE WITH THE BROKEN LOCKING MECHANISM AND SCREW BACK OUT ON THE BOTTOM OF THE CONSTRUCT.
Patient problems: Failure of Implant
MAUDE report 20274018 ↗InjurySep 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS STATED THAT IN TWO SEPARATE EVENTS THE CETRA 3 LEVEL PLATES HAD THE LOCKING MECHANISM POP OFF AND THEREFORE THE SCREW BACKED OUT. IN BOTH SITUATIONS IT WAS A THREE LEVEL PLATE WITH THE BROKEN LOCKING MECHANISM AND SCREW BACK OUT ON THE BOTTOM OF THE CONSTRUCT.
Patient problems: Failure of Implant
MAUDE report 20273791 ↗
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
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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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