BRYAN® Cervical Disc System 6470315Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994181213), received between Jan 9, 2017 and Jan 9, 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 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.

• InjuryJan 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS DISC HERNIATION WITH MYELOPATHY. FOR WHICH PATIENT UNDERWENT A STANDARD ANTERIOR APPROACH FOR CERVICAL ARTHROPLASTY AT LEVELS C5-C6. POST-OP, OVER TIME THE INFERIOR SIDE OF THE IMPLANT LOOKED TO MIGRATE ANTERIORLY. FROM THE FILMS, THE DISTANCE DISC MIGRATED LOOKS ABOUT 3MM. THE SURGEON WAS NOT COMFORTABLE WITH THE DISTANCE THE IMPLANT HAD MIGRATED AND FELT THE IMPLANT NEEDED TO BE REMOVED. ON (B)(6) 2016, AFTER EXPLANTING THE DISC, A CERVICAL FUSION AT C5-C6 WAS PERFORMED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. ON (B)(6) 2016, PATIENT BEGAN TO HAVE SYMPTOMS OF NUMBNESS AND WEAKNESS.

  Patient problems: No Code Available; Numbness; Weakness

  MAUDE report 6232185 ↗