DuraMatrix OnlayRecalls & reported problems across all models

We found 3 models of DuraMatrix Onlay by Collagen Matrix, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2016 and Jul 22, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

1 FDA recall record name at least one of these models by its device identifier.

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

DuraMatrix Onlay recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 13, 2021Terminated

   Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

   Z-0668-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported DuraMatrix Onlay problems

DuraMatrix Onlay models

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

• DuraMatrix Onlay CDSLM45

  Dura Substitute
  1 recall3 reports
• DuraMatrix Onlay CDSLM33

  Dura Substitute
  3 reports
• DuraMatrix Onlay CDSLM22

  Dura Substitute
  1 report

Recent DuraMatrix Onlay adverse event reports

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

• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION, WITH LIMITED DETAILS PROVIDED. FURTHER INFORMATION REGARDING THE PATIENT OR EVENT IS UNLIKELY TO BECOME AVAILABLE. THE PRODUCT INVOLVED IS DURAMATRIX-ONLAY®. A PATIENT EXPERIENCED AN ADVERSE EVENT (AE) CHARACTERIZED AS WOUND DEHISCENCE WITH PURULENT DISCHARGE. THE INITIAL SURGERY WAS (B)(6) 2025 AND THE LOCATION OF THE IMPLANT WAS THE ANTERIOR FOSSA. NO SUTURES, SEALANTS OR OTHER DURAL CLOSURE PRODUCTS WERE USED DURING THE PROCEDURE. NO CSF LEAK WAS OBSERVED POST-PLACEMENT. A DRAINAGE SHUNT WAS USED. A ROUTINE FOLLOW UP VISIT ON (B)(6) 2025 NOTED NO ADVERSE EVENTS. HOWEVER, A SUBSEQUENT FOLLOW-UP VISIT ON (B)(6) 2025 INDICATED WOUND DEHISCENCE ON THE "SCALP, WOUND". THE PATIENT WAS INITIALLY PRESCRIBED CEPHALEXIN WHICH WAS SWITCHED TO DOXYCYCLINE DUE TO SENSITIVITIES. CLINICAL DATA COLLECTION INDICATED THAT THE ADVERSE EVENT WAS UNRELATED TO THE INTERVENTION. NO SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION SURROUNDING PATIENT STATUS OR PATIENT OUTCOME WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22568587 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION, WITH LIMITED DETAILS PROVIDED. FURTHER INFORMATION REGARDING THE PATIENT OR EVENT IS UNLIKELY TO BECOME AVAILABLE. THE PRODUCT INVOLVED IS DURAMATRIX-ONLAY®. A PATIENT EXPERIENCED AN ADVERSE EVENT (AE) CHARACTERIZED AS PNEUMOCEPHALUS AND INCREASED VASOGENIC EDEMA WITH 4 DAYS OF WORD FINDING ISSUES, SHORTNESS OF BREATH AND HEADACHES AND FOUND TO HAVE INTRACRANIAL ABSCESS IN PREVIOUS RESECTION CAVITY. THE INITIAL SURGERY WAS (B)(6) 2025 AND THE LOCATION OF THE IMPLANT WAS THE CONVEXITY. 4-0 SYNTHETIC, NON-ABSORBABLE SUTURES WERE USED. NO SEALANTS OR OTHER DURAL CLOSURE PRODUCTS WERE USED DURING THE PROCEDURE. NO CSF LEAK WAS OBSERVED POST-PLACEMENT. HOSPITALIZATION WAS INDICATED ALONG WITH A WOUND WASHOUT AND CULTURE. BROAD SPECTRUM ANTIBIOTICS NARROWED DOWN TO CEFTRIAXONE WITH EOT (B)(6) 2025. THE OPERATING ROOM CULTURES GREW P. ACNES AND STAPH EPIDERMIDIS. PATIENT HAS DIABETES AND POOR WOUND HEALING. A ROUTINE FOLLOW UP VISIT ON (B)(6) 2025 NOTED NO ADVERSE EVENTS. CLINICAL DATA COLLECTION INDICATED THAT THE ADVERSE EVENT WAS UNRELATED TO THE INTERVENTION. NO FURTHER INFORMATION SURROUNDING PATIENT STATUS OR PATIENT OUTCOME WAS

  Patient problems: Insufficient Information

  MAUDE report 22568586 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR THE EVENT WILL BE PROVIDED. DURAMATRX-ONLAY COLLAGEN DURA MEMBRANE USED ON A PATIENT ON (B)((6) 2025 IN THE ANTERIOR FOSSA. PATIENT WAS PART OF CLINICAL STUDY FOR MENINGIOMA WHO GRADE 1. AT TIME OF INITIAL SURGERY, 3-0 AND 4-0 SYNTHETIC, NON-ABSORBABLE SUTURES WERE USED (NOT COLLAGEN MATRIX, INC. PRODUCTS). NO OTHER DURAL PRODUCTS WERE UTILIZED. A DRAINAGE SHUNT WAS ALSO USED (NOT A COLLAGEN MATRIX, INC. PRODUCT). THERE WERE NO COMPLICATIONS NOTED DURING THE INITIAL SURGERY. THERE WAS NO CSF LEAKAGE AFTER INITIAL PLACEMENT. THE CLINICIAN CLASSIFIED THE HANDLING PROPERTIES OF THE DURAMATRIX-ONLAY PRODUCT AS "GOOD" AND ALSO CLASSIFIED THE ADAPTABILITY OF THE PRODUCT TO ANATOMIC STRUCTURE AS "GOOD." AN ADVERSE EVENT WAS REPORTED ON 5/31/2025, IN WHICH AN INTRACRANIAL ABSCESS POST CRANIECTOMY IN THE BONE FLAP WAS NOTED. CLINICIAN CLASSIFIED THIS AS A SERIOUS, BUT UNEXPECTED, ADVERSE EVENT. HOSPITALIZATION WAS REQUIRED. INTERVENTION REQUIRED AS ADDITIONAL SURGERY WAS PERFORMED TO RE-DO THE CRANIECTOMY AND EVACUATION OF ABSCESS AND WASHOUT.

  Patient problems: Abscess

  MAUDE report 22560140 ↗
• InjuryApr 14, 2022Degraded; Degraded

  IT WAS REPORTED THAT A SURGEON USED DURAMATRIX DURING A SUBOCCIPITAL CRANIECTOMY AND REPORTED THAT THE DURA SUBSTITUTE DISSOLVED AND THEY HAD TO REMOVE IT AND PLACE A LUMBAR DRAIN. SINCE THERE WAS NOT A TIGHT SEAL USING THE DURAMATRIX, CSF WAS ABLE TO LEAK THROUGH. THE PRODUCT WAS REPLACED WITH DURAGEN AND DISCARDED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 14113830 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGEON OBSERVED A CSF LEAK THROUGH THE DMO IN POSTERIOR FOSSA. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE USING ANOTHER PRODUCT. THERE WAS NO DELAY IN PROCEDURE REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 9706844 ↗
• InjuryOct 5, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS INITIALLY REPORTED THAT THE DURAMATRIX ONLAY (CDSLM45) PRODUCT IN COMBINATION WITH DURAMATRIX SUTURABLE (DMS45; EMDR REPORT 2249852-2017-00017) WAS USED AS PART OF A POST AREA FOSSA CRANIOTOMY PROCEDURE WHICH RESULTED IN FOLLOW-UP SURGERY TO FIX A CEREBROSPINAL FLUID LEAK. BASED ON ADDITIONAL INFORMATION RECEIVED ON 10/11/2018, IT HAS BEEN DETERMINED THAT THE DURAMATRIX ONLAY (CDSML45) PRODUCT WAS NOT USED OR ASSOCIATED WITH THE INITIALLY REPORTED INCIDENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6915042 ↗
• MalfunctionDec 8, 2016Material Separation; Material Separation

  THE COMPLAINT STATES THAT THE CLINICIAN NEEDED TO BRING THE PATIENT BACK TO THE OPERATING ROOM DUE TO CEREBROSPINAL FLUID LEAKAGE. IT WAS OBSERVED THAT THE MEMBRANE SEEMED TO PULL APART AND SPLIT INTO LAYERS, THE LEAKAGE WAS OBSERVED STRAIGHT THROUGH THE MIDDLE OF THE MEMBRANE. THE PRODUCT WAS IMPLANTED WITH SUTURES. THE MEMBRANE WAS REMOVED AND REPLACED WITH ANOTHER PRODUCT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6156480 ↗

Other Collagen Matrix, Inc. products

• RegenerOss Resorbable Xenograft2 models · 3 reports · 1 recall
• DuraMatrix Suturable5 models · 37 reports