ATLANTIS® Anterior Cervical Plate System 7200040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994625120), received between Sep 24, 2021 and Nov 22, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2023Biocompatibility; Biocompatibility

  INFORMATION WAS RECEIVED FROM A PATIENT, COMPETENT AUTHORITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH FUSION THERAPY. IT WAS REPORTED THAT THE PATIENT HAD A ATLANTIS C5-7 ANTERIOR FUSION PLATE PLACED FOR DISCS PROTRUDING ONTO SPINAL CORD. PATIENT DEVELOPED AUTOINFLAMMATORY DISORDER, ERYTHRODERMA SWELLING AND EDEMA IN TISSUES AND SKIN WHICH HAS NOT RESOLVED AND FOUND TO BE ALLERGIC TO TWO OF THE IMPLANT METALS - NICKEL AND TITANIUM. THERE WAS ALSO LOCAL SWELLING CAUSING DYSPHAGIA AND ABNORMAL SWELLING AND THICKENING OF TISSUE IN FRONT OF THE DEVICE BEHIND THE UPPER ESOPHAGUS ON CT SCAN. THERE WAS NO PREOP COUNSELLING ON METAL ALLERGY OR GUIDANCE ON PREOP METAL PATCH TESTING. THE PLATE WAS REMOVED. PLATE AND SCREWS WERE PLANNED FOR REMOVAL DUE EFFECTS OF SYSTEMIC METAL ALLERGY TO THE DEVICE COMPONENTS CAUSING LOCAL AND SYSTEMIC ALLERGIC REACTION WITH MULTIORGAN IMPAIRMENT. PREOP IMAGING SHOWED A BROKEN FIXATION SCREW IN THE C7 VERTEBRA AND PERIOPERATIVELY AFTER THE PLATE WAS REMOVED. THE FUSION WAS FOUND TO BE MOBILE - IE THE C5-7 FUSION HAD FAILED AND MY CERVICAL SPINE IS NOW UNSTABLE. THE BROKEN SCREW WILL HAVE CONTRIBUTED TO FUSION FAILURE. THE BROKEN SCREW HAD

  Patient problems: Dysphagia/ Odynophagia; Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 18189162 ↗
• MalfunctionSep 24, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM COMPETENT AUTHORITY VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH MIXED CERVICAL SPO NDYLOPATHY FOR ANTERIOR CERVICAL ACDF SPINAL THERAPY. IT WAS REPORTED THAT ELITE LOCKING RING WAS BROKEN. THERE WAS NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12524391 ↗