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ANATOMIC PEEK PTC Cervical Fusion System 5030841Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CAGE 5030841 ANATOMIC PTC 14X11X8MM · Class 2 · Implant

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 00643169357495), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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

  • Migration or Expulsion of Device1

Patient problems

  • Pain1

Recent adverse event reports

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

  • InjuryNov 15, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DECOMPRESSION AND FUSION AT C5/6 DUE TO CERVICAL DISC HERNIATION. POST -OP, THE PATIENT SUFFERED WITH PAIN IN THE LEFT SHOULDER BLADES. LOSS OF LORDOSIS, CAGE SINKING, AND DISPLACEMENT OF PLATES WERE OBSERVED ABOUT 2 WEEKS AFTER THE OPERATION. THE EVENT ALSO CAUSED CHANGE IN THE ALIGNMENT WHICH LED TO SCAPULAR BONE PAIN.

    Patient problems: Pain

    MAUDE report 7034254 ↗

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Sources and updates

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