DuraGen® Plus DP1045Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780023470), received between Mar 13, 2024 and Dec 27, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

1 other recall cover devices cleared under the same FDA submission (K032693); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THE FOLLOWING INCIDENT DESCRIPTION: "48-YEAR-OLD FEMALE PATIENT ADMITTED TO THE HOSPITAL, IN THE INTERNAL MEDICINE DEPARTMENT FOR MENINGITIS WITH 1280 ELEMENTS/MM3 PREDOMINANTLY LYMPHOCYTIC. 2 MONTHS AFTER A CRANIECTOMY FOR A LEFT FRONTO-TEMPORAL CRANIOMENINGIOMA, TREATED WITH KEPPRA AS PRIMARY PROPHYLAXIS. AFTER REVIEW OF THE LITERATURE, THE POSSIBILITY OF KEPPRA-INDUCED MENINGITIS (IMMUNO-ALLERGIC MECHANISM) PROMPTED THE DISCONTINUATION OF KEPPRA AFTER NEUROLOGICAL ADVICE, BUT THIS HYPOTHESIS SEEMS IMPLAUSIBLE AS THERE IS A PERSISTENT PERSISTENCE OF A LYMPHOCYTIC REACTION DESPITE DISCONTINUATION. BACTERIOLOGICAL AND MYCOLOGICAL ANALYSES OF LUMBAR PUNCTURES DO NOT SUGGEST AN INFECTIOUS ORIGIN. THE MAIN HYPOTHESIS IS THEREFORE THAT OF A POSTOPERATIVE CHEMICAL MENINGITIS. GIVEN THE NEGATIVITY OF THE INFECTIOUS WORKUP AND THE ABSENCE OF A BIOPSIABLE SITE ON THE CT SCAN, CORTICOSTEROID THERAPY WITH TAPERING WAS INITIATED, LEADING TO MARKED IMPROVEMENT AND COMPLETE WITHDRAWAL SYMPTOMATIC TREATMENTS. PATIENT INFORMATION: PATIENT'S CURRENT CONDITION: CORTICOSTEROID THERAPY WITH TAPERING IS INITIATED, LEADING TO MARKED IMPROVEMENT AND COMPLETE WITHDRAWAL OF SYMPTOMATIC

  Patient problems: Meningitis

  MAUDE report 21031016 ↗
• MalfunctionMar 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPORTED THAT DURAGEN PLUS DURAL REGENERATION MATRIX (DP1045) WAS IMPLANTED IN A PATIENT DIAGNOSED WITH MENINGIOMA BRAIN TUMOR. AT THE TIME OF PASSING THE SUTURES INTO THE PATCH, IT BEGAN TO TEAR AND EVEN CAME LOOSE FROM THE TRACTION POINTS. INTRAOPERATIVELY, THE PATIENT DID NOT HAVE ANY DAMAGE/INJURY FROM THE EVENT THAT OCCURRED, AND IT IS HOPED THAT IT WILL NOT CAUSE A FISTULA LATER. THE PATIENT WAS REPORTED TO BE IN SATISFACTORY RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897384 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032693. One submission often covers many models, so check the product and lot details in each record.

• Z-1284-2013 · Mar 28, 2013 · Terminated
  DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the