BRYAN® Cervical Disc System 6470317Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994181237), received between Jan 16, 2017 and Mar 23, 2018 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL DISC ARTHROPLASTY AT C5-6. POST-OP, CYSCT WAS FOUND ON FILMS POSTERIOR TO THE IMPLANT. AS A RESULT OF THIS ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) HAD TO BE PERFORMED IN WHICH THE SURGEON PULLED THE IMPLANT OUT USING A COCHLEAR. THE SURGEON SAID HE BROKE THE ANTERIOR PORTION OF THE POLYURETHANE SHEATH TAKING THE IMPLANT OUT. THE SURGEON INSPECTED THE IMPLANT AND NOTICED THE POSTERIOR PORTION OF THE POLYURETHANE SHEATH WAS DAMAGED AS WELL. HE SAID HE DID NOT BREAK THE POSTERIOR PORTION OF THE POLYURETHANE SHEATH. HE BELIEVES THAT THE POSTERIOR PORTION OF THE POLYURETHANE SHEATH WAS BROKEN PRIOR TO THE REVISION SURGERY AND WITH IT BEING BROKEN THE PARTICLE WEAR CAUSED THE CYST . THE IMPLANT WAS COMPLETED EXPLANTED.

  Patient problems: Cyst(s)

  MAUDE report 7365104 ↗
• InjuryFeb 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT SURGERY AT LEVELS C6-C7; C4-C5 WITH IMPLANTATION OF ARTIFICIAL CERVICAL DISC AT LEVEL C6-C7 DUE TO PRE-OP DIAGNOSIS: NECK PAIN, DISC HERNIATION. ON (B)(6) 2014, THE PATIENT UNDERWENT ANTERIOR CERVICAL DISC FUSION(ACDF) SURGERY AT LEVELS C4-C5,C5-C6,C6-C7 WITH IMPLANTATION OF ANOTHER ARTIFICIAL CERVICAL DISC. ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH BOTH THE DISCS IMPLANTED WERE REMOVED. THE SURGEON STATED THAT THE PATIENT HAD A BRIEF PERIOD OF NECK PAIN RELIEF BUT THAT THE NECK PAIN HAS CONTINUED AND THE PATIENT WAS ALSO EXPERIENCING OCCIPITAL HEADACHES. DISC WERE BEING REMOVED DUE TO PERSISTENT NECK PAIN. REMOVAL OF BOTH DISCS WERE UNCOMPLICATED BUT SURGEON NOTED SOME HETEROTOPIC OSSIFICATION (GRADE POSTEROLATERAL TO ARTIFICIAL DISC REPLACEMENT DEVICE. "HO" WAS REMOVED WITH DRILL. THE ARTIFICIAL DISC REPLACEMENT DEVICE PLUS PERI-PROSTHETIC TISSUE WAS SENT FOR ANALYSIS PER FDA REQUIREMENTS. REVISION TREATMENT INCLUDED THREE LEVEL USING PEEK PLUS ANTERIOR PLATE. TISSUE INGROWTH WAS OBSERVED BETWEEN SUPERIOR AND INFERIOR DEVICE COMPONENTS. METAL DEBRIS WAS VISIBLE IN TISSUE LATERAL TO LP DEVICE.THE CU

  Patient problems: Headache; Inadequate Pain Relief; Neck Pain

  MAUDE report 6309843 ↗
• InjuryJan 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT PRESENTED WITH PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE. FOR WHICH PATIENT UNDER WENT ARTIFICIAL DISC REPLACEMENT (ADR) PROCEDURE. POST-OP, ON AN UNKNOWN DATE, PATIENT PRESENTED WITH NECK PAIN. THE IMPLANT MIGRATED ANTERIORLY. FOR WHICH, PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016.

  Patient problems: Neck Pain; No Code Available

  MAUDE report 6253002 ↗