BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL SPINE SEALANT 2ML XTA

    MDR report key: 2502015 · Received March 1, 2012

    Report

    Report Number
    1219930-2012-00198
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Report Date
    January 31, 2012
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    NQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SPINAL FUSION. ACCORDING TO THE REPORTER: THERE WAS SMALL FLUID RETENTION CAUDAL PART MESH IMPLANT. START DATE: (B)(6) 2012. SEVERITY: MILD. RELATIONSHIP TO DEVICE: DEFINITE RELATIONSHIP. OUTCOME: ONGOING. NODULAR SCAR CAUDAL PART MESH IMPLANT FOUND DURING CT SCAN. ADD'L INFO REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL SPINE SEALANT 2ML XTA DURASEAL SPINE SEALANT 2ML XTA NQR UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR