DuraGen® Suturable DURS1391Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780023494), received between Oct 17, 2021 and Dec 22, 2023 — classified as 1 injury, 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K043427); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionDec 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384308 ↗
• InjuryOct 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVERSE EVENT WAS REPORTED UNDER (B)(6) CLINICAL STUDY ((B)(6)) WITH THE FOLLOWING INFORMATION: IT WAS REPORTED THAT A MALE PATIENT IN THIS STUDY HAD A CEREBROSPINAL FLUID (CSF) LEAK. A REPLACEMENT OF LUMBAR DRAIN RESOLVED THE ISSUE WITH NO FURTHER PROBLEMS. SEE ADDITIONAL DETAILS OF THE ADVERSE EVENT AS FOLLOWS: DEVICE INFORMATION: CAT#/PRODUCT CODE# (DURS1391). SURGERY DATE: ON (B)(6) 2021. DATE OF DISCHARGE: ON (B)(6) 2021. PATIENT DIAGNOSIS: BRAIN TUMOR. SURGICAL REGION: SUPRATENTORIAL. SURGICAL PROCEDURE: TRANSPHENOIDAL TUMOR REMOVAL. ADVERSE EVENT: AE TERM: CEREBROSPINAL FLUID LEAK. ADVERSE EVENT ONSET OR START DATE: ON (B)(6) 2021. DID THE AE RESULT IN AN INITIAL OR PROLONGED HOSPITALIZATION: NO. DID THE AE REQUIRE INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE?: NO. DETAILS OF INTERVENTION: REPLACEMENT OF LUMBAR DRAIN. OUTCOME: RESOLVED WITHOUT SEQUELAE (CSF RHINORRHEA RESOLVED ON (B)(6) 2021 AFTER REPLACEMENT OF LUMBAR DRAIN. NO FURTHER ISSUES). ADVERSE EVENT RESOLUTION/END DATE: ON (B)(6) 2021.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 12643961 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043427. One submission often covers many models, so check the product and lot details in each record.

• Z-1283-2013 · Mar 28, 2013 · Terminated
  Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handl
• Z-1081-2010 · Jan 13, 2010 · Terminated
  Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx only. Manufacturer: Integra LifeSciences Corporation, Plain