ATLANTIS® Anterior Cervical Plate System 7200025 (UDI 00763000889821)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · PLATE 7200025 ATL VISION ELITE 25MM · Class 2 · Implant
All models of ATLANTIS Anterior Cervical Plate System (46)
Data updated Oct 18, 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 00763000889821), received between Dec 30, 2025 and Dec 30, 2025 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY C7-L1 INTERBODY FUSION PROCEDURE IN A PATIENT. PATIENT MEDICAL HISTORY: ANXIETY AND MIGRAINE HEADACHES DIAGNOSTICS: ACTION RESULT: ABNORMAL MILD TO MODERATE INCREASED TRACER ACTIVITY IS SEEN IN THE LOWER CERVICAL SPINE AT THE T7-L1 LEVEL. THIS IS SIMILAR TO THE PREVIOUS BONE SCAN. MOTION AT THIS LEVEL CANNOT BE EXCLUDED. MODERATE FOCAL ACTIVITY IS SEEN IN THE UPPER CERVICAL SPINE AT C3-C4 SUGGESTING INCREASED ARTHRITIC CHANGES AT THIS LEVEL IN COMPARISON TO THE PREVIOUS BONE SCAN. IT WAS REPORTED THAT THE SUBJECT DEVELOPED A CRACK AT THE INDEX FUSION SITE. C7-T1 PSEUDARTHROSIS WAS CONFIRMED INTRAOPERATIVELY. PATIENT WAS HOSPITALIZED FROM (B)(6) 2025. PATIENT UNDERWENT ADDITIONAL SURGERY ON (B)(6) 2025 FOR REMOVAL OF IMPLANTS AT C4-T1 LEVELS AND ADDITIONAL DISCECTOMY / HEMICORTECTOMY AT C7-T1. NO PRODUCT MALFUNCTION REPORTED. AS PER SITE ASSESSMENT, EVENT IS CAUSALLY RELATED TO STUDY DEVICE AND STUDY PROCEDURE. PATIENT WAS ADMINISTERED OPIATES OR NARCOTICS MEDICATION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REG
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23921533 ↗
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
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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