DuraMatrix Suturable DMS13Recalls & reported problems
Collagen Matrix, Inc. · Collagen Dura Membrane 1in x 3in (2.5cm x 7.5cm) · Class 2 · Implant
- 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 00813954020396), received between Jul 23, 2025 and Jul 23, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fungal Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A MEDWATCH FORM, MW5171348, WAS RECEIVED BY COLLAGEN MATRIX, INC. ON JUNE 24, 2025. THE MEDWATCH FORM INDICATES THAT A DURAMATRIX GRAFT WAS USED ON A PATIENT FOR A CRANIECTOMY ON (B)(6) 2025. TISSEEL FIBRIN GLUE (NOT A COLLAGEN MATRIX, INC. PRODUCT) WAS ALSO USED DURING THIS INITIAL PROCEDURE. VARIOUS REVISIONS AND MEDICAL INTERVENTIONS TOOK PLACE AFTER THE INITIAL GRAFT PLACEMENT. DURAL REPAIR, WOUND EXPLORATION AND DEBRIDEMENT OCCURRED ON (B)(6) 2025. A LUMBAR DRAIN PLACEMENT WAS PERFORMED ON (B)(6) 2025 AND SUBSEQUENTLY REMOVED ON (B)(6) 2025. A LUMBAR DRAIN REPLACEMENT WAS PERFORMED ON (B)(6) 2025. THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION AT THE SITE OF THE SURGERY AND THE GRAFT WAS EXPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE REPLACEMENT LUMBAR DRAIN WAS REMOVED. CULTURES FROM THE GRAFT WERE POSITIVE FOR ASPERGILLUS. A (B)(6) 2025 CULTURE OBTAINED FROM AN ASPIRATE AT THE BACK OF THE PATIENT'S NECK GREW ASPERGILLUS. ADDITIONALLY, CULTURES OBTAINED FROM THE (B)(6) 2025 EXPLANTED GRAFT ALSO TESTED POSITIVE FOR ASPERGILLUS. VARIOUS MEDICATIONS WERE PRESCRIBED TO THE PATIENT. FOR THE GROWTH OF METHICILLIN (SUSCEPTIBLE STAPHYLOCOCCUS AUREUS), THE FOLLOWING WAS PRESCRIBED: VA
Patient problems: Fungal Infection
MAUDE report 22580901 ↗
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.