ATLANTIS® Anterior Cervical Plate System 3125515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994241252), received between Jun 12, 2020 and Jul 8, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2020Device Slipped; Device Slipped

  ON 2020-JUN-04 MPXR-(B)(4) (FOR, HCP, REP) INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN UNKNOWN SPINAL TH ERAPY. PRE-OPERATIVE DIAGNOSIS WAS LUMBAR DEGENERATION IT WAS REPORTED THAT DURING PROCEDURE THE SCREW AND WIRE SLIPPED WHEN THE SCREW WAS IMPLANTED, SO THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER NEW SCREW. THERE WERE NO PATIENT COMPLICATIONS. UPDATE RECEIVED ON 08JUNE2020- THE SCREW SLIPPED. THE SCREW SLIPPED AND THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER NEW SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10244171 ↗
• MalfunctionJun 12, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STENOSIS; AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT TWO LEVELS. INTRA-OP, THREADS OF THE SCREW STRIPPED OFF WHILE PLACING IT INTO THE PLATE. NO FRAGMENT OF THE STRIPPED SCREW REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10146874 ↗

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