DURAFORM 80-1478Recalls & reported problems
Cerenovus, Inc. · DURAFORM Dural Graft Implant 3 Inches x 3 Inches (7.62cm x 7.62cm) · Class 2 · Implant
All models of DURAFORM (4)
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 10886704036739), received between Apr 17, 2018 and Apr 17, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Contamination With Biological Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Contamination With Biological Material1
- Microbial Contamination of Device1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2018Device Contamination With Biological Material; Microbial Contamination of Device; Device Contamination With Biological Material
THE FOLLOWING WAS REPORTED ON A SPREADSHEET WHICH NATUS RECEIVED FROM CODMAN ON 19MARCH2018: "A PATIENT DEVELOPED AN INFECTION AFTER DURAFORM WAS USED AND A REVISION SURGERY WAS PERFORMED." EVENT DATE: (B)(6). UNK A SURGEON REVISED A SURGERY AFTER SEVERAL DAYS OF INITIAL SURGERY DUE TO INFECTION. THEY FOUND DURAFORM WAS INFECTED BY CERTAIN TYPES OF BACTERIA. HE SAID HE SAW SEVERAL CASES OF INFECTION ON DURAFORM. SURGEON FEELS THAT THE DEVICE CONTRIBUTED TO THE PROBLEM. DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: Unspecified Infection
MAUDE report 7438568 ↗
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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