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ATLANTIS® Anterior Cervical Plate System 876-815Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SCREW 876-815 VA SELF TAPPING 4.0X15MM · 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
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00673978955100), received between Jul 6, 2017 and Jul 6, 2017 — classified as 1 injury.

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.

Most reported problems

Device problems

  • Break1

Patient problems

  • Discomfort1
  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 6, 2017Break; Break

    IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVE DIAGNOSED WITH CERVICAL SPONDYLOSIS DUE TO WHICH THE PATIENT UNDERWENT ANTERIOR CERVICAL SPINE SURGERY IN WHICH THE PLATE AND SCREWS WERE IMPLANTED. POST-OPERATIVE, ONE OF THE SCREW(S) IMPLANTED WERE REPORTED TO BE FRACTURED. THE PATIENT COMPLAINED OF DISCOMFORT AND A HOARSE VOICE AS A RESULT OF THIS EVENT. PATIENT HAS NOT YET ACHIEVED COMPLETE FUSION.

    Patient problems: Discomfort; No Code Available

    MAUDE report 6688811 ↗

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Sources and updates

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