ATLANTIS® Anterior Cervical Plate System 7200085Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994624949), received between Nov 23, 2018 and Nov 23, 2018 — 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2018Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C3-T1 DUE TO DEGENERATIVE DISC DISEASE AND HERNIATED DISC. THE POSTERIOR PORTION OF THE SURGERY WAS PERFORMED ON (B)(6) 2017. ON AN UNKNOWN DATE, POST-OP, THE PATIENT COMPLAINED OF PAIN, DYSPHAGIA AND DIFFICULTY EATING. THE PATIENT WAS NOT FOLLOWED UP BY THE OPERATING PHYSICIAN AND SUBSEQUENTLY ENDED UP IN A REHAB FACILITY FOR OVER A YEAR AND LOST CONSIDERABLE WEIGHT DUE TO INABILITY TO EAT. AS PER THE REPORTED INFORMATION, IN THE INITIAL OPERATION, THE OPERATING SURGEON HAD TRAPPED THE ESOPHAGUS UNDER THE TOP PART OF THE PLATE AND INSERTED ONE SCREW WHICH WENT DIRECTLY THROUGH THE ESOPHAGUS. ONLY ONE SCREW WAS PLACED AT THE TOP OF THE PLATE (AT C3) AND WAS NOT LOCKED DOWN. THIS SCREW BACKED OUT BY 3MM. HENCE, ON (B)(6) 2018, THE REVISION ACDF WAS PERFORMED AT C3-T1, IN WHICH THE PLATE WAS EXPLANTED AND WAS REPLACED WITH PLATE FROM ANOTHER MANUFACTURER. THE SURGEON (PERFORMING THE REVISION) REPORTED THAT THE CAUSE OF DYSPHAGIA WAS THAT THE SCREW WAS INSERTED INTO THE ESOPHAGUS AFTER THE PLATE TRAPPED THE ESOPHAGUS. NO PATIENT COMPLICATIONS WERE REPORTED AFTER THE REVISION SURGERY.

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 8100002 ↗