CETRA 19-0124Recalls & reported problems
Orthofix US LLC · 1-LEVEL PLATE ASSEMBLY, 24MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18257200120314), received between Sep 18, 2023 and Sep 18, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
- Activation, Positioning or Separation Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
INFORMATION PROVIDED STATES THAT THE PATIENT UNDERWENT AN ACDF, ANTERIOR CERVICAL DISCETOMY AND FUSION, SURGERY ON (B)(6), 2023. ADDITIONAL INFORMATION PROVIDED ON SEPTEMBER 1, STATES THAT THE SURGERY WAS SCHEDULED AS A 360 DEG PROCEDURE PERFORMING BOTH ANTERIOR AND POSTERIOR FUSION. DURING THE ANTERIOR PORTION OF THE SURGERY, AFTER SEATING THE PLATE, THE SURGEON ATTEMPTED TO REDUCE A LISTHESIS WHEN ONE OF THE PEDICAL SCREWS PULLED THROUGH THE PLATE. THE SCREW AND PLATE REMAIN IMPLANTED. A SECONDARY SURGERY IS REQUIRED TO COMPLETE THE POSTERIOR SEGMENT OF THE PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 17765546 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- 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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