BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMATRIX SUTURABLE

    MDR report key: 10927116 · Received December 1, 2020

    Report

    Report Number
    10927116
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    August 31, 2020
    Report Date
    November 9, 2020
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A CHIARI MALFORMATION REPAIR IN THE FIRST QUARTER OF THE YEAR. ON (B)(6) THE PATIENT FELL FORWARD HITTING HIS HEAD AND A SUDDEN MENINGOCELE DEVELOPED AT THE OPERATIVE SITE. A RAPID MRI SHOWED A PSEUDOMENINGOCELE AND LIKELY A SMALL DEFECT AT THE SITE OF THE DURAL GRAFT WITH SOME SEPARATION OF THE MUSCLES. THE HYPOTHESIS WAS THAT THE MUSCLES WERE ATTACHED TO THE DURA/GRAFT AND MIGHT HAVE BEEN PULLED DURING HIS FALL, CAUSING A SMALL TEAR. THE PATIENT WAS OBSERVED AND REMAINED CLINICALLY WELL, WITH NO FURTHER ENLARGEMENT OF THE COLLECTION, WHICH REMAINED SOFT. BECAUSE THE FLUID COLLECTION PERSISTED DESPITE 8 WEEKS OF CONSERVATIVE MANAGEMENT, THE PATIENT UNDERWENT PSEUDOMENINGOCELE REPAIR. DURING SURGERY A TEAR IN THE CENTER OF THE GRAFT WAS ENCOUNTERED, WITH INTACT SUTURE LINE BETWEEN GRAFT AND NATIVE DURA. THE CENTER OF THE GRAFT WAS RESECTED BACK TO FIBROTIC AND/OR VASCULARIZED TISSUE AND A NEW CELLULOSE DURAL GRAFT WAS PLACED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392750 DURAMATRIX SUTURABLE DURA SUBSTITUTE GXQ COLLAGEN MATRIX, INC. DMS33 1902281121

    Patients

    Seq Age Sex Outcome Treatment
    1 1825 DA