DuraMatrix CDSM33Recalls & reported problems
Collagen Matrix, Inc. · Collagen Dura Substitute Membrane 3in x 3in (7.5cm 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 00813954020211), received between Jun 26, 2024 and Jun 26, 2024 — 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
- 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.
InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CLINICIAN PERFORMED A POSTERIOR FOSSA DECOMPRESSION FOR CHIARI MALFORMATION AND HOLOCORD SYRINX UTILIZING DURAPLASTY TECHNIQUE. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2024. AFTER PERFORMING THE DECOMPRESSION, THE CLINICIAN WAS SEWING IN THE DURAMATRIX GRAFT. CLINICIAN REPORTED THAT TWO SIDES OF THE GRAFT "SUTURED FINE." THE TOP LINE, UNFORTUNATELY, SHREDDED AND TORE WITH ANY TOUCH, WHETHER THEN CLINICIAN WAS TRYING TO PUT A STICK IN IT OR JUST GRAB IT AND HOLD IT WITH A PICK-UP (TOOTHED OR NOT). THE CLINICIAN ATTEMPTED TO SUTURE TO THE MIDDLE OF THE GRAFT WITH THE SAME POOR RESULTS. THE CLINICIAN ALSO TRIED TO PLACE A PATCH GRAFT AND HAD THE SAME PROBLEM OF TEARING WITH MINIMAL MANIPULATION. THE CLINICIAN TRIED TO REINFORCE WITH TISSEAL, DURAL ONLAY (DURAGEN), AND ADHERUS; THESE PRODUCTS ARE NOT MANUFACTURED BY COLLAGEN MATRIX, INC. DUE TO THE "POOR RESULTS" FROM THE DURAMATRIX, THE INITIAL SURGERY WAS DELAYED BY 1.5 HOURS. ON (B)(6) 2024 THE PATIENT WENT TO THE ER AND HAD A CSF LEAK. THE PATIENT WAS ADMITTED TO THE ICU. THE CLINICIAN NOTED "THE PATIENT HAS HAD NUMEROUS LABS AND IVS AND WILL REQUIRE ANTIBIOTICS AND DIAMOX AND SURGERY TONIGHT AND LIKELY TOMORROW MORNING TO TRY
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 19615904 ↗
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.