ATLANTIS® Anterior Cervical Plate System 7200025 (UDI 00613994625182)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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994625182), received between Aug 30, 2019 and May 27, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2021Break; Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, FOREIGN) REGARDING A PATIENT WITH CERVICAL SPONDYLOSIS PLUS THORACIC SPINE FRACTURE FOR ANTERIOR CERVICAL INTERNAL FIXATION SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANTATION IS ALMOST COMPLETE, AND IT FALLS OFF WHEN LOCKED, AND THEN THERE IS NO OTHER WAY BUT TO TAKE IT OUT. THE LOCKING MECHANISM IS BROKEN. THE EVENT DIDN'T CAUSE THE PATIENT TO EXPERIENCE SYMPTOMS OR COMPLICATIONS. DIRECTLY CHANGED TO AN ELITE BOARD OF THE SAME TYPE (THE SIZE IS ONE SIZE LARGER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11891852 ↗MalfunctionAug 30, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C5-6 DUE TO DEGENERATIVE DISC DISEASE/STENOSIS. INTRA-OP, WHILE FINAL TIGHTENING THE SET SCREW ON THE PLATE SHEERED OFF FROM THE LOCKING MECHANISM. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8949204 ↗
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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