DuraMatrix-Onlay Plus DMOP45Recalls & reported problems
Collagen Matrix, Inc. · Collagen Dural Regeneration Membrane 4in x 5in (10.0cm x 12.5cm) · Class 2 · Implant
- 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 00813954021300), received between Jan 9, 2017 and Jan 26, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Bacterial Infection1
- Hemorrhage, Subdural1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE DMOP45 PRODUCT WAS PLACED AT AN UNKNOWN DATE. IT WAS REPORTED THAT IT COLLECTED BLOOD FORCING COMPLICATIONS AND REMOVAL.
Patient problems: Insufficient Information
MAUDE report 13359680 ↗InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED, THAT A CUSTOMER PERFORMED A SURGERY ON A LARGE MENINGIOMA AND USED THE PRODUCT TO REPAIR THE DURAL DEFECT. THE PATIENT RETURNED AS HE WAS DETERIORATING AND IT TURNED OUT THAT THERE WAS AN INFECTION IN THE DURAL GRAFT, WHICH WAS LATER DETERMINED TO BE A P ACNES INFECTION. THE INFECTION SEEMED TO BE HELD IN THE MIDDLE OF THE GRAFT. IT IS UNKNOWN IF THE PRODUCT WAS REMOVED OR REPLACED.
Patient problems: Bacterial Infection
MAUDE report 8719706 ↗InjuryJan 9, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DURING FOLLOW-UP CRANIOPLASTY PROCEDURE THE CLINICIAN OBSERVED THAT THE DURAMATRIX ONLAY PLUS MEMBRANE WAS ADHERING TO THE BRAIN AND WAS ALSO CAUSING SUBDURAL HEMATOMA BECAUSE THE BARRIER DIDN'T ALLOW FLUID TO PASS THROUGH.
Patient problems: Hemorrhage, Subdural
MAUDE report 6234535 ↗
Other Dura Substitute devices
- Durepair® 62100Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall6 reports
- Durepair® 62105Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall5 reports
- Durepair® 62110Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall3 reports
- DuraMatrix Onlay CDSLM45Collagen Matrix, 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
- DURAFORM 80-1477USCerenovus, Inc. · DURA SUBSTITUTE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.