Biodesign G34979Recalls & reported problems
Cook Biotech Incorporated · Biodesign Duraplasty Graft · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002349794), received between Oct 18, 2018 and Oct 18, 2018 — classified as 1 injury.
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
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Abscess1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PROFESSOR (B)(6) PERFORMED AN ENDOSCOPIC TRANSNASAL REPAIR OF A SKULL BASE FRACTURE IN THE ANTERIOR ETHMOID ROOF. THE (B)(6) 2018 PROCEDURE INCLUDED IMPLANTING A BIODESIGN DURAPLASTY GRAFT IN THE (B)(6) FEMALE PATIENT. PRIOR TO SURGERY THE PATIENT PRESENTED WITH A SPONTANEOUS CSF LEAK AND HAD A KNOWN HISTORY OF GENERALIZED SEIZURES. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS SEEN POST REPAIR REGULARLY. ON (B)(6) 2018, THE PATIENT PRESENTED WITH A GENERALIZED GRAND-MAL SEIZURE. AN URGENT BRAIN CT SHOWED A POSSIBLE SMALL INTRACRANIAL ABSCESS AT THE GRAFT SITE. THE PATIENT WAS ADMITTED TO THE ICU AND UNDERWENT EMERGENCY SURGERY TO EXPLANT THE GRAFT. THE PATIENT WAS IN THE HOSPITAL FOR 7 DAYS ON ANTIBIOTICS. THE PATIENT RECOVERED AND WAS DISCHARGED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 7978687 ↗
Other DURA SUBSTITUTE devices
- Durepair® 62100Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall6 reports
- Durepair® 62105Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall5 reports
- Durepair® 62110Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall3 reports
- DuraMatrix Onlay CDSLM45Collagen Matrix, Inc. · Dura Substitute1 recall3 reports
- Durepair® 62111Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall1 report
- Durepair® 62106Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall1 report
- Durepair® 62158Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall0 reports
- DURAFORM 80-1477USCerenovus, Inc. · DURA SUBSTITUTE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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