Biodesign G31092Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002310923), received between Jul 1, 2021 and Jul 1, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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.

• InjuryJul 1, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT HAD AN ALLERGIC REACTION. THE GRAFT WAS SUTURED IN WITH A 5-0 PROLENE ON A C-1 NEEDLE. THE CUSTOMER REQUESTED A SMALL SAMPLE TO ATTEMPT TO PIN DOWN THE ALLERGY SOURCE. THE SURGEON REPORTED TO THE COOK AREA REPRESENTATIVE THAT THE PATIENT CAME BACK WITH A SUSPECTED TUMOR RECURRENCE. THE PATIENT WAS REOPERATED ON AND THERE WAS NOT A TUMOR PRESENT, BUT RATHER WHAT APPEARED TO BE AN ALLERGIC REACTION. THE AREA CLEANED UP AND THE SAMPLES WERE SENT FOR TESTING. THE RESULTS DID NOT INDICATE THE REACTION WAS TO BIODESIGN. THE SURGEON USES BIODESIGN OFTEN AND HAS NO CONCERNS. ON 06/29/2021, DR. (B)(6) REPORTED ADDITIONAL DETAILS TO CBI. THE PATIENT'S UNDERLYING CONDITION BEING TREATED WAS A MENINGIOMA. THE BIODESIGN DURAL GRAFT WAS IMPLANTED AS A REPLACEMENT OF THE DURA THAT WAS REMOVED AS PART OF THE TUMOR RESECTION. THE GRAFT WAS FIXED INTO PLACE WITH PROLENE SUTURE. THERE WAS NO CONCURRENT MEDICATIONS AT THE TIME OF GRAFT PLACEMENT OR NEW MEDICATIONS POST-OP. THERE WERE ALSO NO OINTMENTS, CREAMS OR SPECIAL WOUND CARE BANDAGES USED ON THE PATIENT. THE PATIENT UNDERWENT A REPEAT CRANIOTOMY FOR RESECTION OF THE GRAFT. THE PATIENT'S COURSE OF EVENTS WAS DETERMINED TO BE A GRANULOMATO

  Patient problems: Foreign Body Reaction

  MAUDE report 12104153 ↗

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