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ATLANTIS® Anterior Cervical Plate System 7200055Recalls & reported problems

Medtronic Sofamor Danek, Inc. · PLATE 7200055 ATL VISION ELITE 55MM · Class 2 · Implant

All models of ATLANTIS Anterior Cervical Plate System (46)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994625304), received between May 20, 2020 and May 1, 2024 — classified as 2 malfunctions.

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

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break1
  • Migration or Expulsion of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMay 1, 2024Break; Break

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). LEVELS IMPLANTED: C4-7. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS MYELOPATHY. IT WAS REPORTED THAT THE DEVICE LOCKING MECHANISM CAME OFF. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE LOCKING MECHANISM BROKE OFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19219358 ↗
  • MalfunctionMay 20, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CERVICAL MYELOPATHY; AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). 4 WEEKS POST-OP, THE CRANIAL SCREW OF THE PLATE BACKED OUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AND NO ADDITIONAL SURGERY HAS BEEN PERFORMED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10075647 ↗

Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices

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Sources and updates

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