DuraMatrix-Onlay Plus DMOP57Recalls & reported problems
Collagen Matrix, Inc. · Collagen Dural Regeneration Membrane 5in x 7in (12.5cm x 17.5cm) · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813954021317), received between Oct 2, 2017 and Sep 5, 2023 — classified as 3 injuries.
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
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- No Apparent Adverse Event1
Patient problems
- Complaint, Ill-Defined1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LIMITED INFORMATION WAS PROVIDED. CLINICAL DATA COLLECTION SITE REPORTED THE PATIENT SUFFERED AN EARLY WOUND INFECTION 8 DAYS POSTOP AFTER DURAMATRIX ONLAY PLUS (DMOP) WAS USED IN A SURGERY (TYPE OF SURGERY AND DATE OF SURGERY NOT SPECIFIED). REVISION SURGERY WAS REQUIRED FOR WOUND WASHOUT. DURING THE REVISION SURGERY, THE DMOP GRAFT WAS REPLACED WITH ANOTHER DMOP GRAFT, BUT "ONLY BECAUSE THE PRIOR GRAFT [FROM THE INITIAL SURGERY] WAS EXPLORED FOR INFECTION." IT WAS NOTED THE INITIAL DMOP GRAFT WAS NOT TO BE INVOLVED AND THERE WAS NO ISSUE WITH THE INITIAL DMOP GRAFT THAT WAS PLACED. NO ADDITIONAL EVENT OR PATIENT INFORMATION PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 17683331 ↗InjuryJan 3, 2019No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE CLINICIAN USED A DURAMATRIX ONLAY PLUS PRODUCT THAT WAS APPROXIMATELY 1 MONTH PAST ITS EXPIRATION DATE TO COMPLETE AN EMERGENCY CRANITOMY/ CRANIECTOMY AS IT WAS THE ONLY AVAILABLE PRODUCT ON THE SHELF.
Patient problems: No Code Available
MAUDE report 8214852 ↗InjuryOct 2, 2017Appropriate Device Problem Term/Code Not Available
THE CLINICIAN REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO THE COLLAGEN MEMBRANE TRAPPING BLOOD AND AIR. DURING THE REVISION SURGERY THE PRODUCT WAS REMOVED AND REPLACED.
Patient problems: Complaint, Ill-Defined
MAUDE report 6908860 ↗
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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