BRYAN® Cervical Disc System 6470316Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994181220), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryAug 16, 2023Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C5/C6 CERVICAL TDR FOR AN INDICATION OF C5/C6 RADICULOPATHY. IT WAS REPORTED THAT THERE WAS INTERNAL FAILURE OF CAGE NOT ALLOWING TO COMPRESS. TWO BRYAN DISCS WITH LOT 0247320W AND 0263928W WERE IMPLANTED, SO IT IS NOT SURE WHICH LOT NUMBER THE FAILED CAGE CAME FROM. THE BRYAN DISC FAILED CAUSING INSTABILITY AND THE ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE IMPLANT AND REPLACED WITH A CORPECTOMY CAGE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553749 ↗