CETRA 19-0238Recalls & reported problems
Orthofix US LLC · 2-LEVEL PLATE ASSEMBLY, 38MM · Class 2 · Implant
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 18257200120413), received between Jun 20, 2023 and Jun 20, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
Patient problems
- Headache1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2023Material Separation; Material Separation
INFORMATION PROVIDED STATES THAT AN UNKNOWN SYSTEM WAS ORIGINALLY IMPLANTED AT C3/4 IN (B)(6) 2019. A REVISION WAS PERFORMED TO EXTEND THE FUSION TO C4/5 IN (B)(6) 2022 AT THAT TIME A CETRA 2 LEVEL PLATE WAS IMPLANTED AT C3/4 - C4/5. ON (B)(6) 2023 THE PATIENT PRESENTED IN ER DUE TO HEADACHES. X-RAYS WERE TAKEN AND IT WAS FOUND THAT THE LOCKING MECHANISM ON THE CETRA PLATE HAD DISENGAGED AND ONE OF THE SCREWS HAD MIGRATED DISTAL TO THE PLATE. THE PATIENT WAS TAKEN TO OR WHERE THE CETRA PLATE, LOCKING MECHANISM AND 5 OF THE SCREWS WERE REMOVED. THE CAUDAL SCREW WAS LEFT IN THE PATIENT. A SUBSEQUENT SURGERY BY ENT TO REMOVE THE REMAINING SCREW IS SCHEDULED FOR (B)(6) 2023.
Patient problems: Headache
MAUDE report 17166324 ↗
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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