DuraMatrix Suturable DMS45Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813954020426), received between Apr 20, 2016 and Jan 22, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Hole In Material” (2 reports).

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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Material Puncture/Hole

  LIMITED INFORMATION WAS PROVIDED. CUSTOMER STATED THE DURAMATRIX SUTURABLE PRODUCT WAS USED ON A PATIENT IN 2019 (DATE AND NATURE OF PROCEDURE NOT SPECIFIED). PATIENT WAS "REOPENED" ON (B)(6) 2025 AND THERE WAS A MASSIVE HOLE IN THE GRAFT AND CSF WAS LEAKING OUT. NO DETAILS SURROUNDING THIS SECOND OPERATION WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, INCLUDING WAS THE SECOND OPERATION CONDUCTED AS MEDICAL INTERVENTION TO ADDRESS THE CSF LEAKAGE, WHAT WAS THE SECOND OPERATION PERFORMED, AND CURRENT PATIENT STATUS. NO FURTHER INFORMATION HAS BEEN PROVIDED. AS IT WAS CONFIRMED INTERVENTION WAS REQUIRED AND A SECOND OPERATION WAS PERFORMED, THIS EVENT IS BEING REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 24146750 ↗
• InjuryDec 19, 2025Material Disintegration; Material Disintegration

  CUSTOMER REPORTED A PATIENT UNDERWENT A SUBOCCIPITAL CRANIECTOMY WITH DURAL REPAIR USING DURAMATRIX SUTURABLE PRODUCT. THE GRAFT WAS PROPERLY SUTURED AND THE SUTURE LINE REMAINED INTACT POSTOPERATIVELY. THE PATIENT INITIALLY RECOVERED WELL. ABOUT 2-3 WEEKS AFTER INITIAL IMPLANTATION, THE CENTRAL PORTION OF THE GRAFT DISINTEGRATED DESPITE THE INTACT SUTURE LINE. THIS UNEXPECTED DEGRADATION RESULTED IN A PSEUDOMENINGOCELE. REVISION SURGERY WAS REQUIRED, IN WHICH A REOPERATION CONFIRMED THE SUTURE LINE WAS INTACT BUT THE CENTER OF THE GRAFT HAD DISINTEGRATED. MULTIPLE SUBSEQUENT PROCEDURES WERE REQUIRED, INCLUDING: REPLACEMENT OF THE GRAFT WITH DURAGUARD (NOT A COLLAGEN MATRIX, INC. PRODUCT), PLACEMENT OF A VENTRICULAR CATHETER, AND INSERTION OF A VP SHUNT. CUSTOMER REPORTED AN EVENT DATE OF 10/20/2025 HOWEVER IT WAS NOT SPECIFIED IF THIS WAS THE DATE OF THE INITIAL SURGERY OR THE DATE OF A SUBSEQUENT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER, INCLUDING WHEN ALL PROCEDURES OCCURRED, HOW THE UNEXPECTED GRAFT DEGRADATION WAS DISCOVERED, AND THE PATIENT OUTCOME/PATIENT STATUS. THE CUSTOMER STATED NO FURTHER INFORMATION REGARDING THE EVENT WOULD BE PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23854947 ↗
• InjurySep 15, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT REQUIRED INITIAL REVISION SURGERY DUE TO A BREAKDOWN OF THE GRAFT AND CSF LEAK. FURTHER CLARIFICATION REPORTED THAT SUTURES WERE USED TO REPAIR THE LEAKAGE. THE PATIENT THEN REQUIRED A SECOND REVISION SURGERY AFTER A HOLE AND CSF LEAK WERE NOTICED. THE GRAFT WAS REMOVED AND REPLACED WITH AUTO GRAFT FROM THE PATIENT'S LEG. THE PATIENT WAS REPORTED TO BE HEALING WELL.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 10535448 ↗
• InjuryOct 5, 2017Material Disintegration; Material Disintegration

  THE CLINICIAN REPORTED THAT A REVISION SURGERY WAS PERFORMED AS A RESULT OF CSF LEAK 11 DAYS FOLLOWING THE INITIAL POST AREA FOSSA CRANIOTOMY. DURING THE REVISION SURGERY THE CLINICIAN OBSERVED THAT THE DURAMATRIX SUTURABLE PRODUCT WAS BREAKING DOWN ON THE EDGES AND HAD A SMALL AMOUNT OF FLUID BUILDUP UNDERNEATH. AS PART OF THE INITIAL REPORTING THE DISTRIBUTOR'S SALES REPRESENTATIVE STATED THAT DURAMATRIX SUTURABLE PRODUCT WAS USED IN CONJUNCTION WITH DURAMATRIX ONLAY PRODUCT (EMDR REPORT 2249852-2017-00018). BASED ON FOLLOW-UP INFORMATION IT HAS BEEN DETERMINED THAT DURAMATRIX SUTURABLE PRODUCT WAS THE ONLY PRODUCT USED IN THE PROCEDURE AND THE DURAMATRIX ONLAY PRODUCT WAS NOT INVOLVED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6914978 ↗
• MalfunctionMay 9, 2017Hole In Material; Hole In Material

  CLINICIAN OBSERVED A HOLE IN THE CENTER OF THE MEMBRANE. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE MEMBRANE WITH ANOTHER DURAMATRIX PRODUCT. PATIENT WAS REPORTED TO BE IN GOOD CONDITION AT THE TIME OF REPORT.

  Patient problems: No Code Available

  MAUDE report 6555904 ↗
• InjuryJul 16, 2016Hole In Material

  DURING A REVISION SURGERY AS A RESULT OF CEREBROSPINAL FLUID LEAKAGE THE CLINICIAN OBSERVED A HOLE IN THE CENTER OF THE DURAMATRIX SUTURABLE MEMBRANE. A DRAIN WAS INSTALLED DURING THE REVISION SURGERY, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 5799985 ↗
• InjuryApr 20, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AFTER IMPLANTATION OF THE DEVICE FOLLOWING CRANIOTOMY FOR TUMOR RESECTION, THE PHYSICIAN OBSERVED CEREBROSPINAL FLUID LEAKAGE. THE DEVICE WAS REMOVED AND REPLACED WITH A DIFFERENT PRODUCT THAT THE FACILITY HAD AVAILABLE. NO DELAY IN SURGERY WAS REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 5591446 ↗