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DuraMatrix CDSM11Recalls & reported problems

Collagen Matrix, Inc. · Collagen Dura Substitute Membrane 1in x 1in (2.5cm x 2.5cm) · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813954020181), received between Feb 24, 2016 and Feb 24, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

  • Device Operates Differently Than Expected1

Patient problems

  • Adhesion(s)1

Recent adverse event reports

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

  • MalfunctionFeb 24, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

    DURING A POSTERIOR LUMBAR PROCEDURE, THE SURGEON ATTEMPTED TO SUTURE A DURAMATRIX MEMBRANE IN PLACE. THE SURGEON WAS USING A PROLENE SUTURE AND EVEN AFTER HYDRATING THE DURAMATRIX THE SUTURE TORE RIGHT THROUGH THE EDGES OF THE MEMBRANE.

    Patient problems: Adhesion(s)

    MAUDE report 5456517 ↗

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.