Integra® DuraFlex® BP10405Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780511342), received between Mar 18, 2021 and Mar 18, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Puncture/Hole” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH CHIARI MALFORMATION UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2020 WITH IMPLANTATION OF AN RTI SURGICAL, INC. DURAFLEX SUTURABLE GRAFT. THE FIRST WEEK OF (B)(6) 2021, THE PATIENT DEVELOPED A CEREBROSPINAL FLUID (CSF) LEAK. ON (B)(6) 2021, THE GRAFT WAS RESUTURED AND AUGMENTED WITH MUSCLE. TWO DAYS POST-OPERATIVELY, A CSF LEAK DEVELOPED AND A LUMBAR DRAINED WAS PLACED FOR 5 DAYS. ANOTHER CSF LEAK DEVELOPED AND VP SHUNT WAS PLACED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT HAD PURULENT CSF DRAINAGE. ON (B)(6) 2021, THE PHYSICIAN PERFORMED A RE-EXPLORATION OF THE SUBOCCIPITAL WOUND WITH REMOVAL OF THE GRAFT, VP SHUNT AND IMPLANT OF NEW GRAFT (UNKNOWN) AND PLACEMENT OF AN EXTERNAL VENTRICULAR CSF DRAIN. THE EXPLANTED DURAFLEX GRAFT WAS DESCRIBED AS HAVING A 1.5CM HOLE IN THE CENTER, THE GRAFT WAS ADHERENT TO PARENCHYMA. TO DATE, REQUESTED ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

  Patient problems: Cerebrospinal Fluid Leakage; Purulent Discharge

  MAUDE report 11516068 ↗