ATLANTIS® Anterior Cervical Plate System 3120313Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994239679), received between Dec 1, 2017 and Mar 21, 2018 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT C5/6 ANTERIOR CERVICAL DISCECTOMY FUSION. POST-OP, PATIENT HAD PAIN AFTER THE SURGERY. ALLEGEDLY, "PATIENT FEELS THAT THE SCREWS STICKING OUT OF HER NECK AS WELL AS WHEN SHE TOUCHES THAT AREA OF HER NECK IT THROBS".

  Patient problems: Inadequate Pain Relief; Neck Pain

  MAUDE report 7359029 ↗
• InjuryDec 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR DISCECTOMY AND FUSION AT C3-C7. POST-OP, THE LEVELS AT C4-5 AND C5-6 COLLAPSED AND THE IMPLANTED SCREWS AT C5-C6 LOOSENED AND CAME OUT OF THE PLATE EVEN THOUGH THE LOCKING MECHANISM WAS LOCKED. PATIENT SUFFERED DUE TO NECK PAIN. PATIENT UNDERWENT REVISION SURGERY (ANTERIOR CERVICAL DISCECTOMY AND FUSION) FOR REMOVAL OF THE IMPLANTS.

  Patient problems: Neck Pain

  MAUDE report 7074073 ↗
• InjuryDec 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR DISCECTOMY AND FUSION AT C3-C7. POST-OP, THE LEVELS AT C4-5 AND C5-6 COLLAPSED AND THE IMPLANTED SCREWS AT C3-C4 LOOSENED AND CAME OUT OF THE PLATE EVEN THOUGH THE LOCKING MECHANISM WAS LOCKED. ONE OF THE 13MM SCREWS COMPLETELY CAME OUT OF THE PLATE AND WAS FLOATING FREE IN THE PATIENT DUE TO WHICH PATIENT SUFFERED WITH NECK PAIN. THE PATIENT UNDERWENT REVISION SURGERY (ANTERIOR CERVICAL DISCECTOMY AND FUSION) TO REMOVE THE IMPLANTS.

  Patient problems: Neck Pain

  MAUDE report 7074072 ↗
• InjuryDec 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR DISCECTOMY AND FUSION AT C3-C7. POST-OP, THE LEVELS AT C4-5 AND C5-6 COLLAPSED AND THE IMPLANTED SCREWS AT C3-C4 LOOSENED AND CAME OUT OF THE PLATE EVEN THOUGH THE LOCKING MECHANISM WAS LOCKED. ONE OF THE 13MM SCREWS COMPLETELY CAME OUT OF THE PLATE AND WAS FLOATING FREE IN THE PATIENT DUE TO WHICH PATIENT SUFFERED WITH NECK PAIN. THE PATIENT UNDERWENT REVISION SURGERY (ANTERIOR CERVICAL DISCECTOMY AND FUSION) TO REMOVE THE IMPLANTS.

  Patient problems: Neck Pain

  MAUDE report 7074069 ↗
• InjuryDec 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR DISCECTOMY AND FUSION AT C3-C7. POST-OP, THE LEVELS AT C4-5 AND C5-6 COLLAPSED AND THE IMPLANTED SCREWS AT C3-C4 LOOSENED AND CAME OUT OF THE PLATE EVEN THOUGH THE LOCKING MECHANISM WAS LOCKED. ONE OF THE 13MM SCREWS COMPLETELY CAME OUT OF THE PLATE AND WAS FLOATING FREE IN THE PATIENT. PATIENT SUFFERED DUE TO NECK PAIN. PATIENT UNDERWENT REVISION SURGERY (ANTERIOR CERVICAL DISCECTOMY AND FUSION) TO REMOVE THE IMPLANTS.

  Patient problems: Neck Pain

  MAUDE report 7074068 ↗

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