DuraMatrix Onlay CDSLM33Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813954020266), received between Feb 13, 2020 and Jul 22, 2025 — classified as 3 injuries.

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

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 3 most recent of 3 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

  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 ↗
• 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 ↗