DuraMatrix SuturableRecalls & reported problems across all models

We found 5 models of DuraMatrix Suturable by Collagen Matrix, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2015 and Jan 22, 2026 — classified as 28 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DuraMatrix Suturable problems

DuraMatrix Suturable models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DuraMatrix Suturable DMS33

  Dura Substitute
  16 reports
• DuraMatrix Suturable DMS22

  Dura Substitute
  12 reports
• DuraMatrix Suturable DMS45

  Dura Substitute
  7 reports
• DuraMatrix Suturable DMS11

  Dura Substitute
  1 report
• DuraMatrix Suturable DMS13

  Dura Substitute
  1 report

Recent DuraMatrix Suturable adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionDec 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS ADVERSE EVENT OCCURRED OUTSIDE OF THE U.S. HOWEVER, AS THERE IS A SIMILARLY MARKETED DEVICE IN THE U.S., AN MDR IS BEING FILED. LIMITED INFORMATION SURROUNDING THE EVENT WAS PROVIDED. THE CUSTOMER INFORMED THE MANUFACTURER THAT THE DURAMATRIX SUTURABLE PRODUCT WAS UTILIZED ON A PATIENT DURING AN INITIAL SURGERY ON (B)(6) 2023. 7 MONTHS AFTER THE INITIAL SURGERY, REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 AND IT WAS FOUND THAT THE DURAMATRIX SUTURABLE PATCH DID NOT RESORB. THE PATCH "WAS ALMOST INTACT." THE FOLLOWING INFORMATION WAS REQUESTED BUT NOT PROVIDED: INFORMATION SURROUNDING THE INITIAL SURGERY (INCLUDING NATURE OF SURGERY), REASON FOR THE REVISION SURGERY, SURGICAL TECHNIQUE INFORMATION, CURRENT PATIENT STATUS, AND IF THERE ARE ANY FOLLOW-UP VISITS SCHEDULED. REVISION SURGERY WAS REQUIRED FOR THE PATIENT, HOWEVER DETAILS SURROUNDING THE REASON FOR THE REVISION SURGERY WERE NOT PROVIDED. INFORMATION SURROUNDING PATIENT STATUS WAS REQUESTED BUT NOT PROVIDED. COMPLAINANT CONFIRMED THE PATIENT "DID NOT FEEL ANY DISCOMFORT CAUSED BY THE PATCH. THE FOLLOWING INFORMATION WAS REQUESTED: INFORMATION SURROUNDING THE INITIAL SURGERY, REASON FOR THE REVISION SURGERY, SURGICAL

  Patient problems: Insufficient Information

  MAUDE report 23794895 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDWATCH FORM, MW5171348, WAS RECEIVED BY COLLAGEN MATRIX, INC. ON JUNE 24, 2025. THE MEDWATCH FORM INDICATES THAT A DURAMATRIX GRAFT WAS USED ON A PATIENT FOR A CRANIECTOMY ON (B)(6) 2025. TISSEEL FIBRIN GLUE (NOT A COLLAGEN MATRIX, INC. PRODUCT) WAS ALSO USED DURING THIS INITIAL PROCEDURE. VARIOUS REVISIONS AND MEDICAL INTERVENTIONS TOOK PLACE AFTER THE INITIAL GRAFT PLACEMENT. DURAL REPAIR, WOUND EXPLORATION AND DEBRIDEMENT OCCURRED ON (B)(6) 2025. A LUMBAR DRAIN PLACEMENT WAS PERFORMED ON (B)(6) 2025 AND SUBSEQUENTLY REMOVED ON (B)(6) 2025. A LUMBAR DRAIN REPLACEMENT WAS PERFORMED ON (B)(6) 2025. THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION AT THE SITE OF THE SURGERY AND THE GRAFT WAS EXPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE REPLACEMENT LUMBAR DRAIN WAS REMOVED. CULTURES FROM THE GRAFT WERE POSITIVE FOR ASPERGILLUS. A (B)(6) 2025 CULTURE OBTAINED FROM AN ASPIRATE AT THE BACK OF THE PATIENT'S NECK GREW ASPERGILLUS. ADDITIONALLY, CULTURES OBTAINED FROM THE (B)(6) 2025 EXPLANTED GRAFT ALSO TESTED POSITIVE FOR ASPERGILLUS. VARIOUS MEDICATIONS WERE PRESCRIBED TO THE PATIENT. FOR THE GROWTH OF METHICILLIN (SUSCEPTIBLE STAPHYLOCOCCUS AUREUS), THE FOLLOWING WAS PRESCRIBED: VA

  Patient problems: Fungal Infection

  MAUDE report 22580901 ↗
• 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 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A TRIANGULAR PIECE OF DURAMATRIX SUTURABLE (DMS) WAS USED ON A PATIENT AS A PATCH DURING ORIGINAL SURGERY SUBOCCIPITAL CRANIECTOMY WITH C1 LAMINECTOMY AND DURAPLASTY ON (B)(6) 2023. ADHERUS WAS USED DURING THE INITIAL SURGERY ON (B)(6) 2023. TWO MONTHS AFTER SURGERY THE SCALP FLAP BECAME MORE PROTUBERATE. REVISION SURGERY FOR REPAIR WAS PERFORMED (B)(6) 2024 DUE TO PATIENT DEVELOPING A CSF LEAK. ANOTHER DMS PATCH WAS USED TO COVER THE PREVIOUS PATCH PLACED IN ORIGINAL SURGERY. THE SUTURE USED KEPT RIPPING THROUGH THE PATCHES. SURGEON TOOK BOTH PATCHES OUT AND PLACED A SINGULAR NEW PATCH OF DMS. THE SAME ITEM NUMBER AND LOT NUMBER OF THE INITIAL SURGERY AND REVISION SURGERY WERE USED. NO DELAY IN SURGERY WAS REPORTED. IT WAS NOT SPECIFIED WHICH SURGERY THE "NO DELAY" REFERRED TO. REVISON PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION ON PATIENT STATUS OR PATIENT OUTCOME HAS BEEN PROVIDED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18990154 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED DURAMATRIX SUTURABLE WAS USED ON A PATIENT DURING A SUBOCCIPITAL CRANIOTOMY PROCEDURE ON (B)(6) 2023. CUSTOMER STATED ADHERUS WAS UTILIZED DURING THE ORIGINAL PROCEUDRE. A POST-OP CSF LEAK REPAIR WAS DONE ON (B)(6) 2023. IT WAS NOTED DURING THE REVISION SURGERY TO REPAIR THE LEAK, THE GRAFT HAD A TEAR IN THE MIDDLE OF IT. PATIENT STATUS AND PATIENT INFORMATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18628329 ↗
• InjuryFeb 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED DURAMATRIX SUTURABLE WAS USED ON A PATIENT DURING A CHIARI PROCEDURE ON (B)(6) 2023. CUSTOMER STATED ADHERUS WAS UTILIZED DURING THE ORIGINAL PROCEDURE. A POST-OP CSF LEAK REPAIR WAS DONE ON (B)(6) 2023. IT WAS NOTED THAT THE GRAFT HAD A HOLE IN THE MIDDLE OF IT WHEN REVISION SURGERY OCCURRED TO REPAIR THE LEAK. PATIENT STATUS AND PATIENT INFORMATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18628077 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION PROVIDED. A PATIENT DIAGNOSED WITH CHIARI MALFORMATION HAD POSTERIOR FOSSA PROCEDURE PERFORMED ON (B)(6) 2023. DURAMATRIX SUTURABLE WAS USED. FURTHER INFORMATION SURROUNDING THE INITIAL PROCEDURE WAS NOT SPECIFIED. THE PATIENT PRESENTED WITH A CSF LEAK POST-OP, AND HAD TO BE BROUGHT BACK FOR "AT LEAST A SHUNT/DRAIN" TO FIX THE CSF LEAK. CUSTOMER STATED THE PATIENT WAS BROUGHT BACK FOR TWO POST-OP PROCEDURES: ONCE ON (B)(6) 2023 AND ANOTHER TIME ON (B)(6) 2023. PER CUSTOMER, PATIENT WAS "BROUGHT BACK FOR A SHUNT ON (B)(6) AND ALSO HAD A PRIOR SHUNT AFTER HER SURGERY ON (B)(6) 2023." ADHERUS WAS ALSO UTILIZED FOR THIS PATIENT, BUT IT WAS NOT SPECIFIED AT WHAT SURGERY (INITIAL OR ONE OF THE POST-OPS) THE ADHERUS WAS USED. NO ISSUES OR ADVERSE EVENTS REPORTED AFTER REVISION SURGERY. NO FURTHER INFORMATION ON PATIENT STATUS OR PATIENT OUTCOME WAS PROVIDED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18279361 ↗
• InjuryNov 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  LIMITED INFORMATION WAS PROVIDED. CLINICAL DATA COLLECTION SITE REPORTED DURAMATRIX SUTURABLE WAS USED ON A PATIENT IN Q2 2021 FOR A CRANIOPLASTY. THE PATIENT EXPERIENCED HEARING LOSS ON THE RIGHT SIDE. ADHERUS DURAL SEALANT WAS ALSO UTILIZED DURING THE PROCEDURE. NO ADDITIONAL EVENT INFORMATION, PATIENT INFORMATION, OR PATIENT OUTCOME WAS PROVIDED. COMPLAINANT CONFIRMED NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Hearing Impairment

  MAUDE report 18080112 ↗
• 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 ↗
• InjuryOct 10, 2023Material Separation; Material Separation

  CUSTOMER REPORTED THE DURAMATRIX SUTURABLE PRODUCT WAS PLACED IN PATIENT FOR A CHIARI MALFORMATION PROCEDURE ON (B)(6) 2023. THE PATIENT WAS BROUGHT BACK TO SURGERY, AND THE SURGEON STATED THAT THE PERIMETER OF THE GRAFT WAS STILL SUTURED TO THE NATIVE DURA, BUT WHEN GENTLY MANIPULATED WITH AN INSTRUMENT THE GRAFT "FELL APART." CUSTOMER DID NOT SPECIFY THE REASON WHY THE PATIENT WAS BROUGHT BACK TO SURGERY. DATE OF ADDITIONAL SURGERY WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, INCLUDING THE REASON FOR WHY THE PATIENT WAS BROUGHT BACK FOR SURGERY, IF THE PROCEDURE(S) WERE COMPLETED SUCCESSFULLY, IF THERE WERE ANY DELAYS IN PROCEDURE(S), THE CURRENT PATIENT STATUS, AND IF ANY ADDITIONAL FOLLOW-UP SURGERIES WERE REQUIRED. NO ADDITIONAL EVENT OR PATIENT INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17907116 ↗
• 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 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL DATA COLLECTION SITE REPORTED THE DURAMATRIX SUTURABLE GRAFT WAS CUT TOO LARGE AND THERE WAS A MASS EFFECT ON THE PATIENT'S OPTIC NERVE. A REOPERATION WAS PERFORMED TO TRIM THE GRAFT. PATIENT DEVELOPED HYDROCEPHALUS 1 MONTH POSTOP WHICH REQUIRED VP SHUNT PLACEMENT. THERE WAS NO LEAK. NO ADDITIONAL INFORMATION WAS PROVIDED ON PATIENT OUTCOME.

  Patient problems: Hydrocephalus

  MAUDE report 15125055 ↗
• 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 ↗

Other Collagen Matrix, Inc. products

• DuraMatrix Onlay3 models · 7 reports · 1 recall
• RegenerOss Resorbable Xenograft2 models · 3 reports · 1 recall