DuraMatrix-Onlay Conform DMOC13Recalls & reported problems
Collagen Matrix, Inc. · Collagen Dural Regeneration Matrix · 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 00813954026084), received between Jul 15, 2025 and Jul 15, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Headache1
- Speech Disorder1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
AT THE TIME OF THE INITIAL COMPLAINT, LIMITED INFORMATION WAS PROVIDED FOR THE INITIAL COMPLAINT. A NEUROSURGEON REPORTED TO THE DISTRIBUTOR THAT THE PRODUCT INVOLVED IS DURAMATRIX-ONLAY CONFORM, NOTING THAT "FOUR PATIENTS NOW HAVE COME BACK PRESENTING WITH HEADACHES AND ONE HAD A SEIZURE. IN POST-OPERATION CRANIOTOMY SCANS, IT SHOWED INFLAMMATION AROUND THE DURAL GRAFT SITE. THE PATIENT WHO PRESENTED WITH A SEIZURE HAD FLUID AND WAS INFECTED, LEADING TO A TAKE-BACK TO THE OR A MONTH LATER." THE NEUROSURGEON NOTED "ALL CASES WERE CRANIOTOMIES. "ONE WAS A TUMOR, MENINGIOMA, MIDDLE FOSSA/CSF LEAK, AND A SUBDURAL. THIS COMPLAINT PERTAINS TO PATIENT #1, WHO UNDERWENT A CRANIOTOMY AND SUBSEQUENTLY EXPERIENCED A HEADACHE. ADDITIONAL INFORMATION WAS RECEIVED ON 07/07/2025. THE LOT NUMBER AND ITEM NUMBER HAVE BEEN PROVIDED. THE INITIAL SURGERY WAS ON (B)(6) 2025. THE PATIENT DEVELOPED HEADACHES AND DYSARTHRIA ROUGHLY 1 WEEK LATER. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED). MR IMAGING SHOWED DURAL ENHANCEMENT AROUND THE OPERATIVE SITE. THERE WAS A CONCERN FOR SEIZURES AND THE PATIENT WAS STARTED ON MEDICAL THERAPY. WAS MONITORED IN THE HOSPITAL FOR A FEW DAYS AND SYMPTOMS SLOWL
Patient problems: Headache; Speech Disorder
MAUDE report 22506284 ↗
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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