DuraMatrix CDSM22Recalls & reported problems
Collagen Matrix, Inc. · Collagen Dura Substitute Membrane 2in x 2in (5cm x 5cm) · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813954020204), received between Mar 27, 2023 and Jun 26, 2024 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Cerebrospinal Fluid Leakage1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SURGERY FOR A CHIARI MALFORMATION WITH DURAMATRIX ON (B)(6) 2024. THE PATIENT WAS BROUGHT BACK ON (B)(6) 2024 FOR A CSF LEAK DUE TO "GRAFT FAILURE". IT WAS NOTED DURING THE REVISION SURGERY THE DURAMATRIX GRAFT HAD A TEAR. CUSTOMER BELIEVES TEAR WAS FROM THE INITIAL SURGERY. THE CLINICIAN REPORTED A SURGICAL DELAY BUT THE TIME OF DELAY WAS NOT PROVIDED, ONLY THAT THE PATIENT WAS BROUGHT BACK TO DO A SHUNT AND REVISE THE INITIAL CHIARI MALFORMATION SURGERY. IT WAS ALSO REPORTED THAT A DURAL SEALENT ADHERUS WAS USED. ADHERUS IS NOT A COLLAGEN MATRIX, INC. PRODUCT. NO ISSUES ON ADVERSE EVENTS REPORTED AFTER REVISION SURGERY. NO FURTHER INFORMATION PROVIDED ON PATIENT STATUS OR PATIENT OUTCOME.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 19615809 ↗InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LIMITED INFORMATION FROM THE CUSTOMER WAS PROVIDED. THE CUSTOMER STATED THAT DURING A SURGERY ON (B)(6) 2023, DURAMATRIX PRODUCT TORE AS PA WAS SUTURING. INTERVENTION SURGERY REQUIRED TWO-WEEKS POST-OP TO REPAIR. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER, INCLUDING PATIENT STATUS AND NATURE OF THE SURGERY/EVENT, HOWEVER INFORMATION WAS NOT PROVIDED. PATIENT IMPACT AND ANY ADDITIONAL INFORMATION ABOUT THE SURGERY AND PATIENT WAS ALSO REQUESTED BUT NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16620458 ↗
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.