ATLANTIS® Anterior Cervical Plate System 3125517Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994241276), received between Feb 15, 2019 and Feb 15, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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.

• MalfunctionFeb 15, 2019Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS: CERVICAL SPONDYLOSIS PROCEDURE USED: CERVICAL INTERNAL FIXATION IT WAS REPORTED THAT INTRA-OP, SCREW HEAD WAS SLIPPERY AND CANNOT BE USED FOR FIXATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE IMPLANT DID NOT BREAK. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8342222 ↗
• MalfunctionFeb 15, 2019Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS: CERVICAL SPONDYLOSIS PROCEDURE USED: CERVICAL INTERNAL FIXATION IT WAS REPORTED THAT INTRA-OP, SCREW HEAD WAS SLIPPERY AND CANNOT BE USED FOR FIXATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE IMPLANT DID NOT BREAK. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8342217 ↗
• MalfunctionFeb 15, 2019Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS: CERVICAL SPONDYLOSIS PROCEDURE USED: CERVICAL INTERNAL FIXATION IT WAS REPORTED THAT INTRA-OP, SCREW HEAD WAS SLIPPERY AND CANNOT BE USED FOR FIXATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE IMPLANT DID NOT BREAK. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8342195 ↗

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