DuraMatrix-Onlay Plus DMOP11Recalls & reported problems
Collagen Matrix, Inc. · Collagen Dural Regeneration Membrane 1in x 1in (2.5cm x 2.5cm) · 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 00813954021263), received between Dec 12, 2025 and Dec 12, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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
- Off-Label Use1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025Off-Label Use; Off-Label Use
THIS ADVERSE EVENT OCCURRED OUTSIDE OF THE U.S. HOWEVER, AS THERE IS A SIMILARLY MARKETED DEVICE IN THE U.S., AN MDR IS BEING FILED. IT WAS REPORTED THAT A DURAMATRIX HAD BEEN MISTAKENLY USED IN A PATIENT'S HAND INSTEAD OF A BONE GRAFT. THE NURSE GRABBED THE WRONG PRODUCT. PROCEDURE WAS COMPLETED SUCCESSFULLY. SURGEON HAS NO CONCERNS PROVIDED THE GRAFT DISSOLVES AND IS ABSORBED INTO THE BODY. NO FURTHER ADVERSE PATIENT OUTCOMES/CONSEQUENCES REPORTED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE DEVICE HISTORY AND COMPLAINT HISTORY RECORDS WERE REVIEWED AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE PRODUCT LABELLING AND PACKAGING FROM THE REPORTED LOT WAS REVIEWED AND FOUND TO BE CONFORMING. PER THE PRODUCT'S INSTRUCTIONS FOR USE, THE DEVICE IS DESIGNED FOR USE IN CRANIAL OR SPINAL PROCEDURES WHERE PRIMARY SUTURE CLOSURE OF THE DURAL DEFECT MAY NOT BE FEASIBLE. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.
Patient problems: Insufficient Information
MAUDE report 23794894 ↗
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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