CETRA 19-0126Recalls & reported problems
Orthofix US LLC · 1-LEVEL PLATE ASSEMBLY, 26MM · Class 2 · Implant
Data updated Oct 13, 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 18257200120321), received between Oct 30, 2024 and Mar 18, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information3
- Use of Device Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT A SCREW WAS BACKING OUT OF THE CETRA PLATE IN A REVISION CASE ON (B)(6) 2025. THE SURGERY WAS FOR AN ADJACENT LEVEL AND IT WAS REPORTED THAT THE PLATE WAS BEING REMOVED ANYWAY. THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS. IT WAS REPORTED THAT THE LOCKING PLATE WAS INTACT WHEN THE DEVICE WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634258 ↗MalfunctionMar 18, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT A SCREW WAS BACKING OUT OF THE CETRA PLATE IN A REVISION CASE ON (B)(6) 2025. THE SURGERY WAS FOR AN ADJACENT LEVEL AND IT WAS REPORTED THAT THE PLATE WAS BEING REMOVED ANYWAY. THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS. IT WAS REPORTED THAT THE LOCKING PLATE WAS INTACT WHEN THE DEVICE WAS REOMVOED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21633981 ↗InjuryOct 30, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT A FEMALE PATIENT HAD ACDF ON (B)(6) 2023. A PLANNED REVISION ACDF C6/7 WAS PERFORMED ON THE PATIENT ON (B)(6) 2024. ON (B)(6) 2024 THE PATIENT HAD A REMOVAL OF THE CETRA PLATE DUE TO IT BECOMING LOOSE FROM THE (B)(6) 2024 SURGERY. IT WAS REPORTED THAT UPON REMOVAL THE C6 LOCKING MECHANISM WAS SHEERED OFF.
Patient problems: Failure of Implant
MAUDE report 20570541 ↗
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
- Elegance® Anterior Cervical Plate 53430353Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430108Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430240Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430236Clariance · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page