Biodesign G31090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002310909), received between Sep 6, 2016 and Sep 6, 2016 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K031850, K160869); they may or may not involve this specific model.

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.

• InjurySep 6, 2016Adverse Event Without Identified Device or Use Problem

  DR. (B)(6) MENTIONED, AT UCSF'S NEUROSURGERY UPDATE COURSE IN (B)(6), THAT HE HAS BEEN USING THE BIODESIGN DURAL GRAFT IN HIS SPINAL DURA MATER REPAIR PROCEDURES AND HAS BEEN SEEING AN EXCESS FORMATION OF GRANULATION TISSUE. PRODUCT WAS PLACED SIX MONTHS AGO. PATIENT TO UNDERGO REOPERATION ON (B)(6) 2016 AND PRODUCT TO BE EXPLANTED. REASON FOR REOPERATION UNSPECIFIED AT THIS TIME. - (B)(6) 2016. UPDATE: ON (B)(6) 2015, THE PATIENT UNDERWENT A T6-T7 POSTERIOR APPROACH LAMINECTOMY BY DR. (B)(6). DURING THIS INITIAL PROCEDURE, THE DURA WAS FOUND INTACT, BUT THE SPINAL CORD WAS TETHERED TO THE DURA. A BIODESGIN DURAL GRAFT WAS PLACED AS A DURAL SLING. TISSEEL, A FIBRIN SEALANT WAS ALSO USED DURING THIS PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND RECOVERED WITHOUT COMPLICATIONS. THE PATIENT'S ORIGINAL COMPLAINT OF RIGHT LOWER EXTREMITY WEAKNESS RESOLVED FOR SEVERAL MONTHS. IN (B)(6) 2016, THE PATIENT INFORMED THE SURGEON'S OFFICE THAT HE WAS STARTING TO HAVE DECREASED STRENGTH IN HIS BILATERAL LOWER EXTREMITIES. THE PATIENT WAS SEEN BY DR. (B)(6) IN (B)(6) 2016. THE PATIENT'S MOBILITY, STRENGTH, AND SENSATION REPORTEDLY DETERIORATED QUICKLY FROM THE INITIAL NOTIFICATION IN (

  Patient problems: Ambulation or Postural Difficulties; Hyporesponsive to stimuli; Inflammation; No Code Available; Scar Tissue; Weakness

  MAUDE report 5930650 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031850, K160869. One submission often covers many models, so check the product and lot details in each record.

• Z-0834-2025 · Nov 22, 2024 · Open, Classified
  Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile