Sonoma™ 20-0366Recalls & reported problems
Seaspine Orthopedics Corporation · Sonoma Anterior Cervical Plate 3 Level Plate, 66mm · 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 10889981050948), received between May 25, 2018 and May 25, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- 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 25, 2018Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
PATIENT WAS ADMITTED THROUGH ER AFTER UNKNOWN TRAUMATIC EVENT ON (B)(6) 2018. THREE DAYS FOLLOWING ((B)(6) 2018) INDEX SURGERY WAS COMPLETED CONSISTING OF AN ACDF AT C5-C6, C6-C7 TWO-LEVEL IMPLANTS, WITH A PARTIAL CORPECTOMY AT C4-C5. AN ANTERIOR PLATE WAS PLACED ACROSS THE 3-LEVEL SURGICAL SITE. REVISION SURGERY (COMPLETED BY DR. (B)(6)) WAS PERFORMED ON (B)(6) 2018. FOUR SCREWS AT LEVELS C5, C6 & C7 PULLED OUT OF THE VERTEBRAL BODY. THE REVISION PROCEDURE REPLACED THE AFFECTED SCREWS WITH RESCUE SCREWS, WHILE KEEPING THE SAME PLATE IN PLACE. THE C4 SCREWS MAINTAINED HEALTHY PURCHASE. THE REMOVED SCREWS WERE DISCARDED ACCORDING TO HOSPITAL POLICY. PATIENT HAS SINCE RETURNED HOME. SURGEON HAS EXPRESSED NO CONCERN ABOUT OUR DEVICE IN RELATION TO THIS EVENT.
Patient problems: Failure of Implant
MAUDE report 7546561 ↗
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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