BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA LIFE SCIENCES DURAGEN BOVINE PERICARDIUM GRAFT

    MDR report key: 21873322 · Received April 21, 2025

    Report

    Report Number
    MW5169325
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 15, 2025
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ADMITTED FOR ELECTIVE SURGERY ON (B)(6) 2025 FOR CHIARI MALFORMATION DECOMPRESSION. DURING SURGERY, A 4X5 DURAGEN BOVINE PERICARDIUM GRAFT WAS IMPLANTED AND SEWN TO THE DURA TO COMPLETE THE DECOMPRESSION. PATIENT PRESENTED TO EMERGENCY DEPARTMENT ON (B)(6) 2025, DRAINAGE FROM INCISION. TAKEN TO SURGERY ON (B)(6) 2025 FOR CSF LEAK. INTRAOPERATIVELY, IT WAS DISCOVERED THE GRAFT HAD DISINTEGRATED AND THAT IS WHY PATIENT HAD A LEAK. INTEGRA LIFESCIENCES WAS NOTIFIED OF FAILED GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257638 INTEGRA LIFE SCIENCES DURAGEN BOVINE PERICARDIUM GRAFT DURA SUBSTITUTE GXQ INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Hospitalization| L| R