ATLANTIS® Anterior Cervical Plate System 3120316Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994239648), received between Jun 22, 2023 and Jun 22, 2023 — 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.

• InjuryJun 22, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH CAGE, SCREWS AND PLATE USED IN A CERVICAL CORPECTOMY SURGERY. IT WAS REPORTED THAT THE SCREWS USED IN THE PROCEDURE AT THE BOTTOM OF THE CONSTRUCT BROKE, LEADING TO A REVISION SURGERY. THIS WAS AT APPROXIMATELY A ONE YEAR FOLLOW UP IN CLINIC AND DISCOVERED VIA X-RAYS. REVISION SURGERY OCCURRED ON (B)(6) 2023 TO REMOVE BROKEN SCREWS AND HARDWARE AND REPLACE WITH NEW HARDWARE. IT WAS UNDERSTOOD THAT PATIENT WAS NOT FULLY FUSED OR POSSIBLY NOT FUSED AT ALL BY THE 12-MONTH POSTOPERATIVE CHECK. PRE-OPERATIVE DIAGNOSIS FOR THE PATIENT WAS CORPECTOMY. OFF LABEL USAGE OF CAGE WAS REPORTED. PSEUDOARTHROSIS WAS REPORTED WITH SCREWS BREAKAGE. THE NATURE OF POTENTIAL OFF LABEL USAGE WAS DUE TO VERTESTACK WAS UTILIZED IN THE CORPECTOMY CASE, AS CORNERSTONE PSR IS APPROVED FOR USE IN THE CERVICAL REGION AND VERTESTACK IS APPROVED FOR USE IN THE TL REGION. THERE WAS NO MALFUNCTION ASSOCIATED WITH THE PLATE. OFF LABEL USE OF PRODUCT AND PSEUDOARTHROSIS OCCURRED TO PATIENT WAS CONFIRMED FOR CAGE. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17181500 ↗

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-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
• 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