DuraMatrix-Onlay Plus DMOP33Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813954021294), received between Jun 16, 2017 and Sep 5, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS PROVIDED. CLINICAL DATA COLLECTION SITE REPORTED THE PATIENT UNDERWENT SURGERY FOR A RIGHT PARIETO-OCCIPITAL CRANIOTOMY. DURAMATRIX ONLAY PLUS (DMOP) WAS USED DURING SURGERY (SURGERY DATE NOT PROVIDED). PATIENT DEVELOPED PERFORATED DIVERTICULITIS 4 DAYS FOLLOWING THE INITIAL SURGERY, RESULTING IN THE NEED FOR SIGMOID COLECTOMY AND OSTOMY CREATION. THE PERFORATED DIVERTICULITIS MAY HAVE CONTRIBUTED "TO ODD PRESENTATION OF DELAYED AND DEEP WOUND INFECTION WITH MRSA" AT 7 WEEKS POST OP. ALSO AT 7 WEEKS POSTOP, PATIENT REQUIRED WOUND WASHOUT INCLUDING CRANIECTOMY AND DMOP REMOVAL FOR SUPERFICIAL AND DEEP WOULD INFECTION. THE PATIENT ALSO RECEIVED GAMMA KNIFE RADIATION ONE MONTH POSTOP. NO FURTHER EVENT INFORMATION OR INFORMATION RELATED TO PATIENT STATUS OR PATIENT OUTCOME WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Drug Resistant Bacterial Infection

  MAUDE report 17683330 ↗
• InjurySep 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  LIMITED INFORMATION WAS PROVIDED. CLINICAL DATA COLLECTION SITE REPORTED PATIENT UNDERWENT SURGERY MOST RECENTLY ON (B)(6) 2021 FOR A RIGHT FRONTAL CRANIOTOMY. THE DURAMATRIX ONLAY PLUS (DMOP) WAS PLACED DURING THIS OPERATION. PATIENT SUFFERED A DELAYED POST-OP HEMATOMA THAT REQUIRED EVACUATION ON (B)(6) 2021. CLINICIAN REPLACED THE DMOP THAT WAS PLACED DURING THE FIRST OPERATION WITH A SECOND SET OF DMOP DURING THE SECOND SURGERY. THERE WERE NO REPORTED COMPLAINTS OR FURTHER ADVERSE EVENTS AFTER THE SECOND SURGERY WHERE THE SECOND DMOP PRODUCT WAS UTILIZED. THE PATIENT RECEIVED IMMUNOTHERAPY POSTOP. NO ADDITIONAL INFORMATION ON PATIENT STATUS OR PATIENT OUTCOME WAS PROVIDED.

  Patient problems: Hematoma

  MAUDE report 17683329 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS PROVIDED. CLINICAL DATA COLLECTION SITE REPORTED A PATIENT REQUIRED "TAKEBACK SURGERY 8 DAYS POSTOP FOR ENDOSCOPIC ENDONASAL CSF LEAK REPAIR." THE PATIENT HAD INITIALLY UNDERWENT RESECTION OF LARGE SKULL BASE MASS INVADING THE INFRATEMPORAL FOSSA AND PARANASAL SINUSES, WITH A PLANNED FREE FLAP PLACEMENT THE NEXT DAY (DATE OF SURGERIES NOT PROVIDED). DURAMATRIX ONLAY PLUS (DMOP) WAS PLACED OVER THE ANTERIOR TEMPORAL LOBE ALONG WITH FIBRIN GLUE AND A FREE PERICRANIAL GRAFT IN A NON-WATERTIGHT FASHION TO COMPLETE A NON-RIGID CLOSURE IN ANTICIPATION OF THE FREE FLAP PLACEMENT (WHICH WAS SUPPOSED TO BE THE NEXT DAY). THE FREE FLAP PLACEMENT WAS SUPPOSED TO "OBLITERATE THE DEAD SPACE IN THE EXTRACRANIAL COMPARTMENT/PARANASAL SINUSES TO OBLITERATE ANY POTENTIAL CSF FISTULA." THE TAKEBACK SURGERY WAS PERFORMED 8-DAYS POSTOP, AND SHOWED THE DMOP GRAFT WAS IN AN UNCHANGED POSITION AND PLACED AS INTENDED. CLINICIAN CONFIRMED THE "CSF LEAK WAS CAUSED BY FAILURE OF FREE FLAP PLACEMENT, NOT INTRACRANIAL RECONSTRUCTION INCLUDING THE DMOP GRAFT." PATIENT RECEIVED POSTOPERATIVE RADIATION AND CHEMOTHERAPY. FURTHER INFORMATION ON POSTOPERATIVE CARE WAS NOT PROVIDED AND THE DAT

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 17670940 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OPERATIVE INFECTIONS NOTICED. THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AN INCREASE IN INFECTIONS AND THEY BELIEVE IT MAY BE DUE TO THE THIS PRODUCT BEING USED INSTEAD OF THE COMPETITOR PRODUCT. BASED ON LIMITED CORRESPONDENCE AND INFORMATION AVAILABLE, IT IS UNKNOWN IF THE PRODUCT WAS REMOVED OR REPLACED OR IF THERE WAS ANY ADDITIONAL TREATMENT EXECUTED IN ORDER TO RESOLVE THE REPORTED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11126533 ↗
• InjuryJun 16, 2017Fluid/Blood Leak

  FOLLOWING THE INITIAL PROCEDURE WHERE DURAMATRIX ONLAY PLUS WAS USED, THE PATIENT UNDERWENT A REVISION SURGERY AS A RESULT OF A CEREBROSPINAL FLUID LEAK (CSF LEAK). IT IS UNKNOWN HOW THE SURGEON CIRCUMVENTED THE ISSUE. NO ADDITIONAL INFORMATION RELATING TO PATIENT CONDITION FOLLOWING REVISION SURGERY HAS BEEN PROVIDED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6648489 ↗
• MalfunctionJun 16, 2017Hole In Material; Hole In Material

  A REVISION SURGERY WAS PERFORMED 2-3 WEEKS FOLLOWING THE INITIAL CRANIOTOMY PROCEDURE WHERE DURAMATRIX ONLAY PLUS PRODUCT WAS IMPLANTED. DURING THE REVISION SURGERY THE SURGEON OBSERVED A HOLE IN THE CANTER OF THE DURAMATRIX ONLAY PLUS PRODUCT. IT IS UNKNOWN HOW THE SURGEON FIXED THE ISSUE OR IF ANY ADVERSE EFFECTS OCCURED. FOLLOWING FURTHER COMMUNICATIONS, THE SURGEON CONCLUDED THAT THE HOLE MOST LIKELY OCCURRED DUE TO SURGICAL TECHNIQUE RATHER THAN DEVICE PROBLEM.

  Patient problems: Failure of Implant

  MAUDE report 6648478 ↗