Sonoma™ 20-0472Recalls & reported problems
Seaspine Orthopedics Corporation · Sonoma Anterior Cervical Plate 4 Level Plate, 72mm · Class 2 · Implant
Data updated Oct 13, 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 10889981050993), received between May 16, 2017 and May 16, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
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.
InjuryMay 16, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
RADIOGRAPH RECEIVED DEPICTING A 4 LEVEL CERVICAL PLATE WITH BONE SCREWS DETACHED FROM THE C3-C7 VERTEBRAL BODIES. THE BONE SCREWS ARE STILL LOCKED AND SECURED IN PLACE IN THE PLATE. THE FOUR UN-IDENTIFIED ALLOGRAFT HAVE SLIGHTLY SHIFTED ANTERIORLY. IT APPEARS, THE THREE CAUDAL VERTEBRAL BODIES (C5, C6 AND C7) HAVE SLIGHTLY COLLAPSED AND COLUMN IS NOT ALIGNED. MULTIPLE ATTEMPTS TO GAIN INFORMATION ABOUT THE EVENT HAVE BEEN MADE, WITH NO SUCCESS. BASED ON THE SURGEON NAME AND THE HARDWARE DISPLAYED IN THE RADIOGRAPH, SUGGESTS THE ORIGINAL SURGERY WAS LIKELY (B)(6) 2016. CURRENT PATIENT STATUS/CONDITION IS UNKNOWN. IT IS NOT KNOWN WHAT CORRECTIVE ACTION WAS TAKEN OR IF A REVISION HAS OCCURRED. BASED ON THE DISASSOCIATION OF THE PLATE, REVISION SURGERY IS LIKELY.
Patient problems: Failure of Implant
MAUDE report 6571390 ↗
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.
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