DuraMatrix Suturable DMS33Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00813954020419), received between Dec 28, 2015 and Jun 26, 2024 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Torn Material” (4 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 16 most recent of 16 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

  IT WAS REPORTED BY THE SURGEON THAT TWO WEEKS POST-OP, THE PATIENT PRESENTED WITH A CSF LEAK AND A REVISION SURGERY WAS PERFORMED. NO INFORMATION SURROUNDING INITIAL SURGERY (DATE OF INITIAL SURGERY NOT PROVIDED). THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM ON (B)(6) 2024 DUE COMPLICATIONS DIRECTLY RELATED TO THE DURAMATRIX SUTURABLE PRODUCT. DURING THE REVISION SURGERY THE SURGEON FOUND THE PATCH WAS COMPLETELY DISINTEGRATED. THE PATIENT NOW HAS VENTRICULOPERITONEAL (VP) SHUNT. DISCHARGED WITH FOLLOW UP ON (B)(6) 2024 FOR SEDATED BRAIN MRI AND SUTURE REMOVAL. ADHERUS WAS ALSO USED DURING THE PROCEDURE (LOT NO. 11235216) BUT IT IS UNCLEAR IF IT WAS USED DURING THE INITIAL SURGERY OR THE REVISION SURGERY. ADHERUS IS A DURAL SEALANT AND IS NOT MANUFACTURED BY COLLAGEN MATRIX, INC. THE EXACT DATE OF THE REVISION SURGERY WAS NOT PROVIDED. NO FURTHER INFORMATION PROVIDED ON PATIENT STATUS OR PATIENT OUTCOME.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 19615819 ↗
• InjuryOct 10, 2023Material Separation; Material Separation

  CUSTOMER REPORTED THE DURAMATRIX SUTURABLE (DMS) PRODUCT WAS USED ON A PATIENT IN THREE SPEARATE INSTANCES. THE PRODUCT WAS FIRST IMPLANTED IN A PATIENT FOR A SPINE CASE ON (B)(6) 2023. ADHERUS WAS SPRAYED OVER THE TOP OF THE DMS. THE NATURE OF SPINE CASE WAS REQUESTED BUT NOT PROVIDED. THE PATIENT WAS BROUGHT BACK TO SURGERY ON (B)(6) 2023. THE SURGEON NOTED THE DMS WAS STILL SUTURED AROUND THE PERIMETER OF THE GRAFT, BUT THE MIDDLE WAS "SPLIT" OPEN. THE SURGEON INDICATED THE GRAFT WAS FRIABLE, AND ATTEMPTED TO SUTURE THE PIECES BACK TOGETHER. ADHERUS WAS SPRAYED OVER THE GRAFT, SURGICEL WAS PLACED OVER THE TOP, AND MORE ADHERUS WAS SPRAYED OVER THE SURGICEL. NO NEW DURAL GRAFT WAS IMPLANTED AT THIS TIME. THE PATIENT WAS BROUGHT BACK TO SURGERY AGAIN ON (B)(6) 2023. THE NATURE OF THE SURGERY AND REASON FOR BRINGING THE PATIENT BACK WAS REQUESTED NOT PROVIDED. THE SURGEON EXPLAINED THE DMS GRAFT WAS "FRIABLE AND FELL APART WHEN MANIPULATED WITH INSTRUMENTATION." TYPE OF INSTRUMENTATION USED WAS REQUESTED BUT NOT PROVIDED. THE DMS GRAFT WAS REMOVED AND REPLACED WITH ANOTHER DMS. THE SAME ITEM NUMBER AND SAME LOT NUMBER USED DURING THE INITIAL SURGERY ON (B)(6) 2023 WAS USED DURING

  Patient problems: Intracranial Pressure Increased

  MAUDE report 17907117 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL DATA COLLECTION SITE REPORTED PATIENT HAD CSF LEAK AND MENINGITIS AFTER DURAMATRIX SUTURABLE PLACEMENT. THE PATIENT RETURNED TO THE OR FOR TUMOR RESECTION AND WOUND REVISION 2 MONTHS POSTOP (REPEATING USE OF THE DURAMATRIX SUTURABLE). THE PATIENT RETURNED TO THE OR AGAIN 5 MONTHS POSTOP FOR SHUNT PLACEMENT AND REPEAT WOUND REVISION. THE COMPLAINANT STATED THE CSF LEAK WAS RELATED TO THE PATIENT'S UNERLYING HYDROCEPHALUS AND WAS NOT RELATED TO A TECHNICAL OR MATERIAL ISSUE. THERE WERE MULTIPLE DEVICES USED, INCLUDING DURAMATRIX SUTURABLE AS INLAY AND A NONSUTURABLE DURAMATRIX AS ONLAY, THEN GLUE ACROSS RECONSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED ON PATIENT STATUS OR PATIENT OUTCOME.

  Patient problems: Cerebrospinal Fluid Leakage; Meningitis

  MAUDE report 15125067 ↗
• MalfunctionJan 26, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A RE-DO CASE, WHERE DURAMATRIX SUTURABLE WAS ORIGINALLY USED, WAS PERFORMED. THERE WAS A HOLE IN THE GRAFT AND A NEW "BODINE TERICAREIUM" WAS USED. THE HOLE WAS DISCOVERED AFTER INITIAL SURGERY. THE ORIGINAL SURGERY DATE (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 13358530 ↗
• InjuryMay 20, 2021Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER REPORTED THAT AFTER IMPLANTATION, THEY SQUIRTED IT WITH SALINE AND IT IMMEDIATELY STARTED LEAKING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 11858454 ↗
• InjuryMay 20, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT A PATIENT HAD A CSF LEAK AND THE CLINICIAN WENT BACK IN TO REPAIR. THE CLINICIAN NOTICED THERE WAS A TEAR IN THE MIDDLE OF THE GRAFT. THE TEAR WAS SUTURED AND DMOP WAS PLACED ON TOP. THE SITE STILL LEAKED SO A SHUNT WAS PLACED ON THE PATIENT TO CIRCUMVENT THE ISSUE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 11858404 ↗
• MalfunctionNov 11, 2020Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER REPORTED THAT A PATIENT WAS TREATED FOR A CHIARI MALFORMATION. THE PATIENT WAS IMPLANTED WITH DURAMATRIX SUTURABLE AND DURASEAL EXACT WAS SPRAYED OVER IT. THE PATIENT THEN HAD A FALL AND THE PHYSICIAN HAD TO DO A 2ND SURGERY DUE TO A CSF LEAK. THE PHYSICIAN STATED THAT THE DURA PATCH FELT LIKE JELLY IN THE MIDDLE BUT WAS STILL SUTURED ALL THE WAY AROUND. THE DURA PRODUCT WAS REMOVED AND REPLACED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 10822629 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHIARI MALFORMATION SURGERY. THE PATIENT SNEEZED POST-OP AND A SUBSEQUENT CSF LEAK STARTED. THE SURGEON WENT BACK IN, AT ABOUT A 4 WEEK MARK TO TRY AND REPAIR THE GRAFT BUT WAS UNABLE TO DO SO. ACCORDING TO THE LIMITED CORRESPONDENCE, THE GRAFT WAS REMOVED AND REPLACED. THERE WAS ABOUT AN HOUR DELAY IN SURGERY.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 8823301 ↗
• InjuryMay 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CLINICIAN REPORTED THAT DURING SURGERY, THERE WAS LEAKING OBSERVED IN THE MIDDLE OF THE IMPLANT. THERE WAS AN ADDITIONAL PRODUCT USED TO STOP THE LEAK. IT IS UNKNOWN IF THE LEAK WAS A CSF LEAK. THERE WERE NO SURGICAL DELAYS OR ANY ADVERSE EVENTS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633220 ↗
• MalfunctionMay 9, 2017Torn Material; Torn Material

  CLINICIAN OBSERVED SMALL TEARS/HOLES AROUND THE EDGES OF THE MEMBRANE WHEN COMPLETING A CRANIOPLASTY PROCEDURE. REVISION SURGERY WAS NOT REQUIRED AND THE PATIENT CONDITION WAS REPORTED AS "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6555876 ↗
• InjuryApr 14, 2017Insufficient Device Problem Information

  FOLLOWING AN INITIAL NEUROSURGERY PROCEDURE, THE CLINICIAN IDENTIFIED CSF LEAKS. AT THE TIME OF INITIAL REPORTING THE REVISION SURGERY HAS NOT YET BEEN PERFORMED AND THE CLINICIAN REPORTED THE POSSIBILITY OF STITCHES RIPPING THROUGH THE MEMBRANE AND CAUSING CSF LEAKS. FOLLOWING THE REVISION SURGERY, THE CLINICIAN PROVIDED ADDITIONAL FEEDBACK STATING THAT ALTHOUGH THE DURAMATRIX SUTURABLE PRODUCT WAS USED, THE SURGEON FOUND THAT HE CSF LEAK WAS NOT CAUSED BY DURAMATRIX SUTURABLE PRODUCT AND HE WILL CONTINUE THE USE OF DURAMATRIX SUTURABLE SINCE THE PRODUCT WAS NOT AT FAULT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6494982 ↗
• MalfunctionFeb 7, 2017Torn Material; Torn Material

  IT WAS REPORTED TO THE DISTRIBUTOR'S SALES REPRESENTATIVE BY A SURGEON THAT DURAMATRIX SUTURABLE DEVICE WAS USED AS INDICATED AND SUTURED INTO PLACE IN A PROCEDURE. THE SURGEON REVISITED THE SITE 2 WEEKS LATER AND COINCIDENTALLY, NOTICED A 4MM TEAR AT THE CORNER OF THE MEMBRANE THAT NEEDED TO BE REPLACED WITH AN ADDITIONAL DURA MEMBRANE. THE REMAINDER OF THE ORIGINAL MEMBRANE WAS LEFT IN PLACE AND THE PATIENT'S CONDITION WAS REPORTED AS GOOD. THERE WAS NO REPORT OF ANY ADVERSE EVENTS EXPERIENCED BY THE PATIENT AS A RESULT OF THE MEMBRANE TEAR.

  Patient problems: Failure to Anastomose

  MAUDE report 6307130 ↗
• InjuryOct 27, 2016Torn Material; Torn Material

  FOLLOWING INITIAL SURGERY ON (B)(6) 2016 A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 DUE TO CEREBROSPINAL FLUID LEAK. DURING THE ATTEMPT TO REPAIR THE LEAK IN THE ORIGINAL IMPLANT, THE IMPLANT TORE AND SHREDDED. THE ORIGINAL IMPLANT WAS REMOVED AND REPLACED WITH A NEW MEMBRANE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6060991 ↗
• MalfunctionApr 21, 2016Torn Material; Torn Material

  THE PRODUCT TORE IN TWO DIFFERENT PLACES DURING SUTURING. ADDITIONAL SUTURES WERE ADDED AROUND THE TEARS AND THE DEVICE REMAINED IMPLANTED. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: Failure to Anastomose

  MAUDE report 5596083 ↗
• InjuryApr 20, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CEREBROSPINAL FLUID LEAK WAS OBSERVED AFTER THE DEVICE WAS SUTURED IN PLACE. DEVICE WAS REMOVED AND REPLACED WITH ANOTHER PRODUCT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 5591514 ↗
• Dec 28, 2015Use of Device Problem

  THE MEDICAL DEVICE WAS IMPLANTED DURING CRANIAL SURGERY PROCEDURE FOUR (4) DAYS PAST THE EXPIRATION DATE. THE ISSUE WAS NOTICED AFTER SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO MEDICAL INTERVENTION, SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5330400 ↗