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DuraMatrix Suturable DMS11Recalls & reported problems

Collagen Matrix, Inc. · Collagen Dura Membrane 1in x 1in (2.5cm x 2.5cm) · 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 00813954020389), received between Apr 14, 2017 and Apr 14, 2017 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • Cerebrospinal Fluid Leakage1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 14, 2017Insufficient Device Problem Information

    FOLLOWING AN INITIAL NEUROSURGERY PROCEDURE, THE CLINICIAN IDENTIFIED CSF LEAKS. AT THE TIME OF INITIAL REPORTING THE REVISION SURGERY HAS NOT YET BEEN PERFORMED AND THE CLINICIAN REPORTED THE POSSIBILITY OF STITCHES RIPPING THROUGH THE MEMBRANE AND CAUSING CSF LEAKS. FOLLOWING THE REVISION SURGERY, THE CLINICIAN PROVIDED ADDITIONAL FEEDBACK STATING THAT ALTHOUGH THE DURAMATRIX SUTURABLE PRODUCT WAS USED, THE SURGEON FOUND THAT HE CSF LEAK WAS NOT CAUSED BY DURAMATRIX SUTURABLE PRODUCT AND HE WILL CONTINUE THE USE OF DURAMATRIX SUTURABLE SINCE THE PRODUCT WAS NOT AT FAULT.

    Patient problems: Cerebrospinal Fluid Leakage

    MAUDE report 6494979 ↗

Other Dura Substitute devices

All Dura Substitute devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.