ATLANTIS® Anterior Cervical Plate System 3120516Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994241153), received between Sep 20, 2017 and Nov 28, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A REGULATORY BODY VIA HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT DIAGNOSED WITH RADICULOPATHY SECONDARY TO A CRACK IN A PREVIOUSLY PLACED GRAFT AT C6/7 AND LOOSENING OF C7 SCREW. PLATE AND SCREW WERE BOTH REMOVED, AND CRACK IN THE GRAFT WAS CONFIRMED UPON INSPECTION. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT ADDITIONAL SURGERY WAS PERFORMED DUE TO LOOSE SCREWS AND EXPLANTED.

  Patient problems: Neuropathy

  MAUDE report 18215376 ↗
• InjuryJun 30, 2023Break; Break

  INFORMATION WAS RECEIVED FROM COMPETENT AUTHORITY, HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE CERVICAL SCREW WAS BROKEN AT C7 (CERVICAL VERTEBRA) FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237247 ↗
• InjuryMay 29, 2018Break; Break

  IT WAS REPORTED THAT, POST-OP, SUPERIOR SCREW FRACTURED IN THE CERVICAL PLATE. PATIENT WENT FOR REVISION SURGERY VIA A POSTERIOR APPROACH. THE ANTERIOR HARDWARE WAS LEFT IN PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7548039 ↗
• InjuryMay 29, 2018Break; Break

  IT WAS REPORTED THAT, POST-OP, SUPERIOR SCREW FRACTURED IN THE CERVICAL PLATE. PATIENT WENT FOR REVISION SURGERY VIA A POSTERIOR APPROACH. THE ANTERIOR HARDWARE WAS LEFT IN PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7548038 ↗
• InjurySep 20, 2017Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT THREE LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION . POST-OP, THE SURGEON FOUND THREE BROKEN SCREW IN CERVICAL VERTEBRAE OF THE PATIENT AS SEEN ON RADIOGRAPH FILM. ON (B)(6) 2017 THE PATIENT REVISION SURGERY AS A RESULT OF THE EVENT. THE BROKEN SCREWS WERE REPLACED WITH DIFFERENT PRODUCTS AND LEVEL OF TREATMENT WAS EXTENDED. TIPS OF THE THREE SCREWS REMAIN IN PATIENT CERVICAL VERTEBRAE. THE PATIENT HAD NOT ACHIEVED SOLID FUSION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6878263 ↗
• InjurySep 20, 2017Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT THREE LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION . POST-OP, THE SURGEON FOUND THREE BROKEN SCREW IN CERVICAL VERTEBRAE OF THE PATIENT AS SEEN ON RADIOGRAPH FILM. ON (B)(6) 2017 THE PATIENT REVISION SURGERY AS A RESULT OF THE EVENT. THE BROKEN SCREWS WERE REPLACED WITH DIFFERENT PRODUCTS AND LEVEL OF TREATMENT WAS EXTENDED. TIPS OF THE THREE SCREWS REMAIN IN PATIENT CERVICAL VERTEBRAE. THE PATIENT HAD NOT ACHIEVED SOLID FUSION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6878262 ↗
• InjurySep 20, 2017Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT THREE LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION . POST-OP, THE SURGEON FOUND THREE BROKEN SCREW IN CERVICAL VERTEBRAE OF THE PATIENT AS SEEN ON RADIOGRAPH FILM. ON (B)(6) 2017 THE PATIENT REVISION SURGERY AS A RESULT OF THE EVENT. THE BROKEN SCREWS WERE REPLACED WITH DIFFERENT PRODUCTS AND LEVEL OF TREATMENT WAS EXTENDED. TIPS OF THE THREE SCREWS REMAIN IN PATIENT CERVICAL VERTEBRAE. THE PATIENT HAD NOT ACHIEVED SOLID FUSION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6878260 ↗

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-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-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