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DuraMatrix Onlay CDSLM22Recalls & reported problems

Collagen Matrix, Inc. · Collagen Dura Substitute Membrane 2in x 2in (5cm x 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 00813954020259), received between Dec 8, 2016 and Dec 8, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1

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.

  • MalfunctionDec 8, 2016Material Separation; Material Separation

    THE COMPLAINT STATES THAT THE CLINICIAN NEEDED TO BRING THE PATIENT BACK TO THE OPERATING ROOM DUE TO CEREBROSPINAL FLUID LEAKAGE. IT WAS OBSERVED THAT THE MEMBRANE SEEMED TO PULL APART AND SPLIT INTO LAYERS, THE LEAKAGE WAS OBSERVED STRAIGHT THROUGH THE MIDDLE OF THE MEMBRANE. THE PRODUCT WAS IMPLANTED WITH SUTURES. THE MEMBRANE WAS REMOVED AND REPLACED WITH ANOTHER PRODUCT.

    Patient problems: Cerebrospinal Fluid Leakage

    MAUDE report 6156480 ↗

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.