BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAFORM 4X5 SPONGE SNGL

    MDR report key: 2010744 · Received March 2, 2011

    Report

    Report Number
    1226348-2011-00078
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 1, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K041518
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFO IS NOT AVAILABLE FOR EVAL. WITHOUT THE DEVICE AND/OR LOT INFO, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFO DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A F/U REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE SURGEON USED A DURAFORM GRAFT 4X5 WITH SIX STITCHES WITHOUT TENSION IN POSTERIOR FOSSE AND ADDITIONALLY USED BERIPLAST SEALANT (BIOTOSCANA). FOUR DAYS AFTER THE SURGERY, THE PT HAD A CSF DRAINAGE BY THE NOSE. THE PT WENT TO A SECOND SURGERY AND THE DURAFORM WAS DIVIDED IN SMALL PIECES. THE SURGEON REPORTED THE DURAFORM WAS DEGRADED JUST FIVE DAYS AFTER THE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAFORM 4X5 SPONGE SNGL DURA SUBSTITUTE GXQ CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention