ATLANTIS® Anterior Cervical Plate System 6190045 (UDI 00613994235886)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994235886), received between Mar 6, 2017 and Aug 9, 2017 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2017Detachment Of Device Component; Detachment Of Device Component

  PRE-OP DIAGNOSIS: HERNIATED DISC IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION DUE TO HERNIATED DISC. POST-OP, THE PLATE APPEARED DAMAGED AT THE PARTS WHICH LINK TOGETHER AND IT SEPARATED IN THE PATIENT. HENCE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 FOR REMOVAL OF PLATE, A NEW PLATE WAS PUT IN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 6776304 ↗
• InjuryMar 6, 2017Break; Break

  PROCEDURE (INITIAL SURGERY): ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WITH PLATING. LEVELS IMPLANTED: C3-C4; C4-C5 PROCEDURE (REVISION SURGERY): REMOVAL OF EXISTING CONSTRUCT, WITH REVISION AND INSTRUMENTED FUSION OF EXISTING AND ADDITIONAL LEVELS. IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST -OP, CEPHALAD SCREW BACKED-OUT AND NON UNION WAS SUSPECTED. DUE TO WHICH PATIENT UNDERWENT AN ADDITIONAL SURGERY ON (B)(6) 2017 IN WHICH CERVICAL PLATE AND SCREWS WERE REMOVED. DURING DISSECTION, SURGEON DISCOVERED THAT CEPHALAD LOCKING MECHANISM WAS NO LONGER ATTACHED TO THE PLATE. SURGEON REMOVED LOCKING MECHANISM, NEXT HE REMOVED PARTIALLY BACKED OUT SCREW AND THEN THE REMAINING SCREWS AND PLATE. THE ENTIRE PLATE/SCREW CONSTRUCT WAS EX-PLANTED, INSPECTED AND ACCOUNTED FOR. THE PRODUCT CAME IN CONTACT WITH PATIENT. PATIENT HAD CONTINUED DEGENERATIVE DISK DISEASE (DDD) SYMPTOMS.

  Patient problems: No Code Available

  MAUDE report 6379659 ↗

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