DuraGen® ID3305Recalls & reported problems
Integra Lifesciences Corporation · DuraGen® Dural Graft Matrix 3in x 3in, 7.5cm x 7.5cm · Class 2 · Implant
Data updated Oct 16, 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 10381780023609), received between Feb 26, 2025 and Feb 26, 2025 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K982180); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPORTED THAT THE PATIENT HAD A CRANIOTOMY FOR TUMOR RESECTION ON (B)(6) 2024, AND A 3X3 DURAGEN (ID3305) WAS PLACED UNDERNEATH THE SKULL FLAP. ON (B)(6)2025, HE HAD TO COME BACK TO THE OPERATING ROOM FOR A SEVERE INFECTION OF THE SURGICAL SITE. WHEN THE SKULL FLAP WAS REMOVED, THE DURAGEN WAS COVERED IN FRANK PUS. THE DURAGEN WAS REMOVED AND THE UNDERLYING TISSUE LOOKED GOOD. HOWEVER, THE PATIENT WILL NEED WEEKS OF ANTIBIOTICS. HE WAS EXTUBATED ON (B)(6)2025 BUT REMAINS IN INTENSIVE CARE.
Patient problems: Bacterial Infection
MAUDE report 21471340 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K982180. One submission often covers many models, so check the product and lot details in each record.
- Z-1282-2013 · Mar 28, 2013 · TerminatedDural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous
Other DURA SUBSTITUTE devices
- Durepair® 62100Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall6 reports
- Durepair® 62105Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall5 reports
- DuraMatrix Onlay CDSLM45Collagen Matrix, Inc. · Dura Substitute1 recall3 reports
- Durepair® 62110Medtronic Ps Medical, 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
- Biodesign G31091Cook Biotech Incorporated · 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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