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BRYAN® Cervical Disc System 6474525Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CUTTER 6474525 15MM · Class 3

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994363817), received between Jun 19, 2017 and Jun 19, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Mechanical Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 19, 2017Mechanical Problem; Mechanical Problem

    PATIENT DEMOGRAPHICS: GENDER: FEMALE IT WAS REPORTED THAT DURING SURGERY, THE CUTTER MALFUNCTIONED. IT WAS UNKNOWN WHETHER THE GEARS WERE SHEARED OR IF IT WAS FAULTY TO BEGIN WITH. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6649421 ↗

Other PROSTHESIS, INTERVERTEBRAL DISC devices

All PROSTHESIS, INTERVERTEBRAL DISC devices →

Sources and updates

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