ATLANTIS® Anterior Cervical Plate System 3120513Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994241122), received between Feb 20, 2017 and Jun 6, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2019Failure to Align; Naturally Worn; Failure to Align; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY SURGERY DUE TO CERVICAL VERTEBRA DEGENERATION. INTRA-OP, SCREW WAS WORN AND SLIPPED. THIS SCREW WAS THEN EXPLANTED COMPLETELY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8674823 ↗
• InjuryFeb 20, 2017Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT SURGERY. POST-OP, X-RAY REVEALED THE IMPLANTED SCREWS BROKE WHICH CAUSED PAIN TO THE PATIENT. ON (B)(6) 2017, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) REVISION SURGERY TO FIX THE BROKEN SCREWS. ABOUT 1/3RD OF THE CANCELLOUS THREADING OF THE SCREW IS REMAINING IN THE PATIENT'S VERTEBRAL BODY.

  Patient problems: No Code Available; Pain

  MAUDE report 6342642 ↗
• InjuryFeb 20, 2017Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT SURGERY. POST-OP, X-RAY REVEALED THE IMPLANTED SCREWS BROKE WHICH CAUSED PAIN TO THE PATIENT. ON (B)(6) 2017, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) REVISION SURGERY TO FIX THE BROKEN SCREWS. ABOUT 1/3RD OF THE CANCELLOUS THREADING OF THE SCREW IS REMAINING IN THE PATIENT'S VERTEBRAL BODY.

  Patient problems: No Code Available; Pain

  MAUDE report 6342641 ↗

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