BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENT

    MDR report key: 2810168 · Received October 31, 2012

    Report

    Report Number
    2520274-2012-02806
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 3, 2012
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE APPROXIMATELY (B)(6) 2012 WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A CRANIOTOMY WITH CALVERIAL BONE GRAFT, MESH AND BONE CEMENT IN (B)(6) 2012. THE PATIENT EXPERIENCED SWELLING OF THE HEAD AND WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF THE BONE CEMENT AND THE MESH. SURGEON REVISED THE PATIENT TO NEW MESH BUT DID NOT REPLACE THE BONE CEMENT. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEMENT LOD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MESH, CEMENT