ATLANTIS® Anterior Cervical Plate System 3120215Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994239921), received between May 7, 2019 and Jun 22, 2023 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH CAGE, SCREWS AND PLATE USED IN A CERVICAL CORPECTOMY SURGERY. IT WAS REPORTED THAT THE SCREWS USED IN THE PROCEDURE AT THE BOTTOM OF THE CONSTRUCT BROKE, LEADING TO A REVISION SURGERY. THIS WAS AT APPROXIMATELY A ONE YEAR FOLLOW UP IN CLINIC AND DISCOVERED VIA X-RAYS. REVISION SURGERY OCCURRED ON (B)(6) 2023 TO REMOVE BROKEN SCREWS AND HARDWARE AND REPLACE WITH NEW HARDWARE. IT WAS UNDERSTOOD THAT PATIENT WAS NOT FULLY FUSED OR POSSIBLY NOT FUSED AT ALL BY THE 12-MONTH POSTOPERATIVE CHECK. PRE-OPERATIVE DIAGNOSIS FOR THE PATIENT WAS CORPECTOMY. OFF LABEL USAGE OF CAGE WAS REPORTED. PSEUDOARTHROSIS WAS REPORTED WITH SCREWS BREAKAGE. THE NATURE OF POTENTIAL OFF LABEL USAGE WAS DUE TO VERTESTACK WAS UTILIZED IN THE CORPECTOMY CASE, AS CORNERSTONE PSR IS APPROVED FOR USE IN THE CERVICAL REGION AND VERTESTACK IS APPROVED FOR USE IN THE TL REGION. THERE WAS NO MALFUNCTION ASSOCIATED WITH THE PLATE. OFF LABEL USE OF PRODUCT AND PSEUDOARTHROSIS OCCURRED TO PATIENT WAS CONFIRMED FOR CAGE. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17181354 ↗
• InjuryJan 31, 2020Migration; Migration

  AS PER PATIENT, ON (B)(6) 2020 THE PATIENT VISITED THE DOCTOR AND HIS PA, THEY INFORMED THAT THE HARDWARE FROM THE IMAGES TAKEN IN JULY REVEALED THAT IT WAS BROKEN. THE CT SHOWED THAT SOME SPOT WIELDING OCCURRED AND AN INCOMPLETE FUSION. HIS ONLY OPTIONS ARE TO WAIT FOR SIX MONTHS TO SEE IF MORE BONE GROWTH OCCURS, OR A POSTERIOR NECK FUSION. HE IS GOING TO WAIT FOR SIX MONTHS, POST THAT THE HARDWARE REMOVED. HE DOES NOT WANT TO TAKE THE RISK OF WHAT BONE GROWTH OR BREAK IN SURGERY. AFTER THAT HE WOULD BE A POSTERIOR FUSION AT THAT POINT.

  Patient problems: Failure of Implant; Pain; Weakness

  MAUDE report 9652263 ↗
• InjuryJan 31, 2020Migration; Migration

  IT WAS REPORTED VIA A PATIENT CALL THAT ON (B)(6) 2019 DURING POST-OP CLINIC VISIT X-RAY REVEALED THAT THE IMPLANTED SCREW WAS LOOSENED AND HAD NOT BEEN FUSED. THE PATIENT IS SUFFERING FROM PAIN, CRACKING, POPPING, LEFT UPPER EXTREMITY WEAKNESS AS A RESULT OF THIS EVENT. PATIENT UNDERWENT PHYSICAL THERAPY AS WELL. ON (B)(6) 2020 HE WAS SCHEDULED TO HAVE CT SCANS AND MRI BUT NO NEW INFORMATION HAS BEEN RECEIVED YET.

  Patient problems: Failure of Implant; Pain; Weakness

  MAUDE report 9652136 ↗
• InjuryJan 31, 2020Migration; Migration

  AS PER PATIENT, ON (B)(6) 2020 THE PATIENT VISITED THE DOCTOR AND HIS PA, THEY INFORMED THAT THE HARDWARE FROM THE IMAGES TAKEN IN JULY REVEALED THAT IT WAS BROKEN. THE CT SHOWED THAT SOME SPOT WIELDING OCCURRED AND AN INCOMPLETE FUSION. HIS ONLY OPTIONS ARE TO WAIT FOR SIX MONTHS TO SEE IF MORE BONE GROWTH OCCURS, OR A POSTERIOR NECK FUSION. HE IS GOING TO WAIT FOR SIX MONTHS, POST THAT THE HARDWARE REMOVED. HE DOES NOT WANT TO TAKE THE RISK OF WHAT BONE GROWTH OR BREAK IN SURGERY. AFTER THAT HE WOULD BE A POSTERIOR FUSION AT THAT POINT.

  Patient problems: Failure of Implant; Pain; Weakness

  MAUDE report 9652133 ↗
• InjuryJan 31, 2020Migration; Migration

  IT WAS REPORTED VIA A PATIENT CALL THAT ON (B)(6) 2019 DURING POST-OP CLINIC VISIT X-RAY REVEALED THAT THE IMPLANTED SCREW WAS LOOSENED AND HAD NOT BEEN FUSED. THE PATIENT IS SUFFERING FROM PAIN, CRACKING, POPPING, LEFT UPPER EXTREMITY WEAKNESS AS A RESULT OF THIS EVENT. PATIENT UNDERWENT PHYSICAL THERAPY AS WELL. ON (B)(6) 2020 HE WAS SCHEDULED TO HAVE CT SCANS AND MRI BUT NO NEW INFORMATION HAS BEEN RECEIVED YET.

  Patient problems: Failure of Implant; Pain; Weakness

  MAUDE report 9652124 ↗
• MalfunctionNov 7, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL DEGENERATION OPERATION DUE TO DEGENERATIVE. INTRA OP, SCREW THREAD WORN OUT. THERE WERE NO PATIENT COMPLICATIONS AT THE TIME OF REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9289032 ↗
• MalfunctionMay 30, 2019Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL FUSION DUE TO CERVICAL DEGENERATION. INTRA-OP, THREAD OF THE SCREW SLIPPED. THE PRODUCT WAS THEN EXPLANTED; AND NO FRAGMENT OF THE PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8653436 ↗
• MalfunctionMay 7, 2019Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY DUE TO CERVICAL DEGENERATION. INTRA-OP, THE TOP INTERNAL HEXAGONAL THREAD OF THE PRODUCT SLID. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8585764 ↗

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-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
• 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