ATLANTIS® Anterior Cervical Plate System 6190025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994235800), received between Jan 31, 2020 and Jan 31, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K063100); they may or may not involve this specific model.

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.

• InjuryJan 31, 2020Fracture; Fracture

  AS PER PATIENT, ON (B)(6) 2020 THE PATIENT VISITED THE DOCTOR AND HIS PA, THEY INFORMED THAT THE HARDWARE FROM THE IMAGES TAKEN IN JULY REVEALED THAT IT WAS BROKEN. THE CT SHOWED THAT SOME SPOT WIELDING OCCURRED AND AN INCOMPLETE FUSION. HIS ONLY OPTIONS ARE TO WAIT FOR SIX MONTHS TO SEE IF MORE BONE GROWTH OCCURS, OR A POSTERIOR NECK FUSION. HE IS GOING TO WAIT FOR SIX MONTHS, POST THAT THE HARDWARE REMOVED. HE DOES NOT WANT TO TAKE THE RISK OF WHAT BONE GROWTH OR BREAK IN SURGERY. AFTER THAT HE WOULD BE A POSTERIOR FUSION AT THAT POINT.

  Patient problems: Failure of Implant; Pain; Weakness

  MAUDE report 9652111 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063100. One submission often covers many models, so check the product and lot details in each record.

• Z-0036-2013 · Aug 30, 2012 · Terminated
  ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee
• Z-0038-2013 · Aug 30, 2012 · Terminated
  PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthoped
• Z-0037-2013 · Aug 30, 2012 · Terminated
  ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38