ATLANTIS® Anterior Cervical Plate System 3120514Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994241139), received between Jul 27, 2019 and Jul 27, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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.

• InjuryJul 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C6-C7. ON AN UNKNOWN DATE, POST-OP, SCREW BROKE AND THE PATIENT EXPERIENCED INFECTION. ADDITIONALLY, FUSION COULD NOT BE ACHIEVED DUE TO THE BROKEN SCREW. HENCE, A REVISION SURGERY (ACDF) WAS PERFORMED ON (B)(6) 2019, WHEREIN THE BROKEN PART OF THE SCREW WAS REMOVED WHILE THE BOTTOM PART OF THE SCREW STILL REMAINED IMPLANTED IN THE PATIENT.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 8834428 ↗
• InjuryJul 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C6-C7. ON AN UNKNOWN DATE, POST-OP, SCREW BROKE AND THE PATIENT EXPERIENCED INFECTION. ADDITIONALLY, FUSION COULD NOT BE ACHIEVED DUE TO THE BROKEN SCREW. HENCE, A REVISION SURGERY (ACDF) WAS PERFORMED ON (B)(6) 2019, WHEREIN THE BROKEN PART OF THE SCREW WAS REMOVED WHILE THE BOTTOM PART OF THE SCREW STILL REMAINED IMPLANTED IN THE PATIENT.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 8834425 ↗
• InjuryJul 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C6-C7. ON AN UNKNOWN DATE, POST-OP, SCREW BROKE AND THE PATIENT EXPERIENCED INFECTION. ADDITIONALLY, FUSION COULD NOT BE ACHIEVED DUE TO THE BROKEN SCREW. HENCE, A REVISION SURGERY (ACDF) WAS PERFORMED ON (B)(6) 2019, WHEREIN THE BROKEN PART OF THE SCREW WAS REMOVED WHILE THE BOTTOM PART OF THE SCREW STILL REMAINED IMPLANTED IN THE PATIENT.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 8834420 ↗

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-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