ATLANTIS® Anterior Cervical Plate System 3120515Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00613994241146), received between Dec 1, 2017 and Jul 29, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50066810 ↗
• MalfunctionMar 13, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C4-C7 DUE TO CERVICAL MYELOPATHY AND RADICULOPATHY. POST-OP, THE IMPLANTED SCREW BACKED OUT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE IS NO FURTHER PLAN FOR REVISION SURGERY YET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8415797 ↗
• MalfunctionJun 26, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL NERVE COMPRESSION AND UNDERWENT ANTERIOR DECOMPRESSION SURGERY OF THE CERVICAL SPINE. DURING SURGERY,THE SET SCREWS SLIPPED. HENCE, THEY HAD TO BE EXPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO ADVERSE EVENT WAS ASSOCIATED WITH THE SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7636643 ↗
• MalfunctionJun 25, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL NERVE COMPRESSION AND UNDERWENT ANTERIOR DECOMPRESSION SURGERY OF THE CERVICAL SPINE. DURING SURGERY, THE SET SCREWS SLIPPED. HENCE, THEY HAD TO BE EXPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO ADVERSE EVENT WAS ASSOCIATED WITH THE SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7636635 ↗
• MalfunctionApr 10, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT PATIENT PRESENTED WITH CERVICAL SPINAL STENOSIS UNDERWENT ANTERIOR CERVICAL DECOMPRESSION. INTRA-OP, THE PRODUCT WAS SLIPPED DURING IMPLANTATION. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7410544 ↗
• MalfunctionMar 7, 2018Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: COMPRESSION OF THE CERVICAL SPINAL CANAL PROCEDURE: ANTERIOR CERVICAL DECOMPRESSION IT WAS REPORTED THAT INTRA-OP, THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7321083 ↗
• MalfunctionDec 19, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL SPONDYLOLISTHESIS, HYPERKERATOSIS , STENOSIS AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION. POST-OP, DURING 3RD WEEK FOLLOW-UP THE SURGEON NOTICED A SCREW BACKING OUT AT THE C7 LEVEL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7127865 ↗
• MalfunctionDec 11, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION. POST-OP, SCREW BACKED-OUT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT. NO REVISION SURGERY WAS SCHEDULED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103600 ↗
• 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 WITH NECK PAIN AND HENCE UNDERWENT REVISION SURGERY (ANTERIOR CERVICAL DISCECTOMY AND FUSION) FOR REMOVAL OF THE IMPLANTS.

  Patient problems: Neck Pain

  MAUDE report 7074085 ↗
• 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 WITH NECK PAIN. AND HENCE UNDERWENT REVISION SURGERY (ANTERIOR CERVICAL DISCECTOMY AND FUSION) FOR REMOVAL OF THE IMPLANTS.

  Patient problems: Neck Pain

  MAUDE report 7074084 ↗
• 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 7074077 ↗
• 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 7074063 ↗

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-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
• 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