ATLANTIS® Anterior Cervical Plate System 6190085Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994235787), received between Oct 13, 2017 and Oct 13, 2017 — classified as 1 injury.

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

• InjuryOct 13, 2017Break; Break

  PROCEDURE USED: ANTERIOR CERVICAL INTERBODY FUSION (ACDF) IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACDF SURGERY AT C3-C7, IN WHICH A TRANSLATIONAL PLATE WAS IMPLANTED. POST-OP, THE PLATE BROKE. PATIENT DID NOT ACHIEVE BONE UNION DUE TO INCOMPLETE FUSION. PATIENT UNDERWENT REVISION FOR REMOVAL AND POSTERIOR FUSION SURGERY. NO FRAGMENT OF THE BROKEN DEVICE WAS LEFT IN THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 6947205 ↗

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