DuraMatrix-Onlay Conform DMOC33Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813954026107), received between Jul 22, 2025 and Jul 22, 2025 — classified as 2 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, 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

  A NEUROSURGEON REPORTED TO THE DISTRIBUTOR THAT THE PRODUCT INVOLVED IS DURAMATRIX-ONLAY CONFORM, STATING THAT "FOUR PATIENTS NOW HAVE COME BACK PRESENTING WITH HEADACHES AND ONE HAD A SEIZURE". THE NEUROSURGEON NOTED "ALL CASES WERE CRANIOTOMIES. "ONE WAS A TUMOR, MENINGIOMA, MIDDLE FOSSA/CSF LEAK, AND SUBDURAL. THIS COMPLAINT PERTAINS TO PATIENT #3, WHO UNDERWENT A CRANIOTOMY AND SUBSEQUENTLY EXPERIENCED A HEADACHE AND SEIZURE. POSTOPERATIVE IMAGING REVEALED INFLAMMATION AROUND THE DURAL GRAFT SITE. THE PATIENT WAS DIAGNOSED WITH FLUID ACCUMULATION AND INFECTION, NECESSITATING A RETURN TO THE OR APPROXIMATELY ONE MONTH POST OP. ADDITIONAL INFORMATION WAS RECEIVED ON 07/07/2025. THE LOT NUMBER AND ITEM NUMBER HAVE BEEN PROVIDED. THE INITIAL SURGERY WAS ON (B)(6) 2025. APPROXIMATELY TWO WEEKS LATER, THE PATIENT DEVELOPED HEADACHES, SEIZURES, AND DYSARTHRIA. MR IMAGING SHOWED DURAL ENHANCEMENT WITH EPIDURAL FLUID COLLECTION. THERE WAS A CONCERN FOR ACTIVE SEIZURES, AND THE PATIENT WAS STARTED ON MEDICAL THERAPY. THE PATIENT UNDERWENT REPEAT SURGERY ON (B)(6) 2025 (REPEAT CRANIOTOMY FOR EXPLORATION) AS THE FLUID COLLECTION DID NOT DECREASE. DURA AND DURAL GRAFT WERE REPORTEDLY NOTED

  Patient problems: Convulsion/Seizure; Headache; Speech Disorder

  MAUDE report 22568612 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NEUROSURGEON REPORTED TO THE DISTRIBUTOR THAT THE PRODUCT INVOLVED IS DURAMATRIX-ONLAY CONFORM, STATING THAT "FOUR PATIENTS NOW HAVE COME BACK PRESENTING WITH HEADACHES AND ONE HAD A SEIZURE." THE NEUROSURGEON NOTED "ALL CASES WERE CRANIOTOMIES. "ONE WAS A TUMOR, MENINGIOMA, MIDDLE FOSSA/CSF LEAK, AND A SUBDURAL. THIS COMPLAINT PERTAINS TO PATIENT #2, WHO UNDERWENT A CRANIOTOMY AND SUBSEQUENTLY EXPERIENCED A HEADACHE. ADDITIONAL INFORMATION WAS RECEIVED ON 07/07/2025. THE LOT NUMBER AND ITEM NUMBER HAVE BEEN PROVIDED. THE INITIAL SURGERY WAS ON (B)(6) 2025. AN EXTENDED STAY IN THE HOSPITAL WAS INDICATED BUT NOTED WORSENING HEADACHES ABOUT 1 WEEK AFTER SURGERY. MR IMAGING SHOWED DURAL ENHANCEMENT AROUND THE OPERATIVE SITE AND EPIDURAL FLUID. THIS WAS MANAGED NONOPERATIVELY. HEADACHES IMPROVED OVER A FEW WEEKS WITH SUBSEQUENT SCANS SHOWING DECREASING FLUID. PATIENT OVERALL DID WELL. NO FURTHER DETAILS REGARDING THE PATIENT'S STATUS FOLLOWING SYMPTOM RESOLUTION HAVE BEEN PROVIDED.

  Patient problems: Headache

  MAUDE report 22568594 ↗