ATLANTIS® Anterior Cervical Plate System 6190052Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994235916), received between Nov 27, 2018 and Nov 27, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• InjuryNov 27, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH NON UNION AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY AT C4-7 LEVELS. POST-OPERATIVELY, THE LOCKING MECHANISM OF THE PLATE WAS BROKEN. AS A RESULT, REVISION SURGERY WAS PERFORMED TO REMOVE THE HARDWARE AND PERFORM RE-INSTRUMENTATION. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE PLATE REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8109379 ↗

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-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
• 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