ATLANTIS® Anterior Cervical Plate System 3120517Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994241160), received between Dec 1, 2017 and Aug 9, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A (HEALTHCARE PROFESSIONAL, RISK MANAGER, REGULATORY BODY) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A ANTERIOR CERVICAL DISCECTOMY AND FUSION. IT WAS REPORTED THAT THE SCREW BROKE. THE DEVICE WAS EXPLANTED AND THE PATIENT WAS HOSPITALIZED. THERE WERE NO PATIENTS SYMPTOMS OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17486318 ↗
• InjuryNov 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH NON UNION AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY AT C4-7 LEVELS. POST-OPERATIVELY, A SCREW WAS BROKEN IN THE BODY OF C7. AS A RESULT, THE BROKEN PORTION OF THE SCREW WAS CAPTURED AND REMOVED FROM THE C7 VERTEBRAL BODY. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE SCREW REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109428 ↗
• 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 C7 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 7074081 ↗
• 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 C7 LOOSENED AND CAME OUT OF THE PLATE EVEN THOUGH THE LOCKING MECHANISM WAS LOCKED. PATIENT SUFFERED DUE TO NECK PAIN. THE PATIENT UNDERWENT REVISION SURGERY (ANTERIOR CERVICAL DISCECTOMY AND FUSION) TO REMOVE THE IMPLANTS.

  Patient problems: Neck Pain

  MAUDE report 7074071 ↗

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-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