ATLANTIS® Anterior Cervical Plate System 6190065Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994235701), received between Sep 17, 2018 and Sep 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionSep 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PRE-OPERATIVE DIAGNOSIS: CEREBROSPINAL FLUID (CSF) LEAK POST SPINAL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) ON (B)(6) 2018 IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN ACDF SURGERY. POST-OP, 7 DAYS LATER, PATIENT PRESENTED WITH CSF LEAKAGE AND HENCE THE PLATE WAS SCHEDULED FOR REMOVAL. DURING REMOVAL, 8 SCREWS WERE REMOVED SUCCESSFULLY, HOWEVER, THE PLATE CAME APART IN THE MIDDLE MOST TRANSLATION. A SINGLE 1CM METAL SLIVER WAS ALSO REMOVED FROM THE PATIENT. THE PLATE DISASSEMBLED BUT NO FRAGMENTS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED POST-OPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7880336 ↗

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-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-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