ATLANTIS® Anterior Cervical Plate System 3120315Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994239655), received between Mar 19, 2021 and Mar 19, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM CONSUMER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT FOR FUSION SPINAL THERAPY. IT WAS REPORTED THAT ON (B)(6). 2020, CUSTOMER UNDERWENT A CERVICAL SPINE ANTERIOR FUSION SURGERY IN WHICH SIX SURGICAL SCREWS. WERE IMPLANTED ON A SURGICAL PLATE ATTACHED TO PATIENTS CERVICAL VERTEBRAE. IN THE SUMMER OF 2020. PATIENT EXPERIENCED PAIN IN THE AREA OF THE IMPLANT THAT STEADILY INCREASED. AS THE PAIN BECAME EXCRUCIATING. PATIENT SOUGHT OUT MEDICAL CARE AND ON (B)(6), 2020. OBTAINED X-RAYS. THE X-RAYS SHOWED THAT TWO OF THE SURGICAL SCREWS HAD BROKEN. DUE TO THE BROKEN SCREWS, THE SURGICAL PLATE (WITH SCREWS ATTACHED) WAS LOOSE AND MOVED ABOUT INSIDE THROAT IN MULTIPLE DIMENSIONS CAUSING UNBEARABLE PAIN. ON (B)(6) 2020. PLAINTIFF UNDERWENT A SECOND PAINFUL AND EXPENSIVE SURGERY TO REPLACE THE TWO BROKEN SCREWS. THE FAILURE OF THE SCREWS CAUSED PATIENT TO EXPERIENCE EXCRUCIATING PAIN. SUFFERING MID LOSS OF FUNCTION LEADING UP TO THE SECOND SURGERY. PATIENT ALSO EXPERIENCED PAIN, SUFFERING AND MEDICAL EXPENSE IN UNDERGOING THE SECOND SURGERY AND THEREAFTER. IMPLANT DATE(S): (B)(6) 2020 PATIENT DEMOGRAPHICS: GENDER- MALE, INITIALS (B)(6), AGE ¿ 53,

  Patient problems: Pain

  MAUDE report 11523503 ↗

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