DuraMatrix Suturable DMS22Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00813954020402), received between Mar 4, 2016 and Dec 12, 2025 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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

  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 ↗
• 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 6494970 ↗
• MalfunctionApr 27, 2016Torn Material; Torn Material

  DURING SUTURING OF DURAMATRIX SUTURABLE PRODUCT, SMALL TEARS NEAR THE EDGE OF THE MEMBRANE WERE OBSERVED. ADDITIONAL SUTURE WAS PLACED AROUND THE TEARS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. DUE TO THE LARGE DEFECT SIZE DURAMATRIX SUTURABLE PRODUCT WAS USED IN CONJUNCTION WITH DUREPAIR PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5611381 ↗
• InjuryApr 20, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING A DURAPLASTY PROCEDURE AND AFTER THE DEVICE WAS IMPLANTED, THE PHYSICIAN OBSERVED CEREBROSPINAL FLUID LEAKING THROUGH THE GRAFT. THE DEVICE REMAINED IMPLANTED IN THE PATIENT. NO DELAY IN SURGERY OR PATIENT INJURY WAS REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 5591487 ↗
• InjuryMar 4, 2016Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED POST-OPERATIVE CEREBROSPINAL FLUID LEAK AND INFECTION. THE SURGERY WILL BE PERFORMED AGAIN AND THE DEVICE WILL BE EXPLANTED.

  Patient problems: Cerebrospinal Fluid Leakage; Unspecified Infection

  MAUDE report 5481091 ↗