BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 2542776 · Received April 12, 2012

    Report

    Report Number
    3004788213-2012-00001
    Event Type
    Injury
    Date Received
    April 12, 2012
    Date of Event
    March 12, 2012
    Report Date
    April 12, 2012
    Manufacturer
    NA
    Product Code
    ODP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY OF C5-C6 TO ADD POSTERIOR CERVICAL LATERAL SCREWS DUE TO QUESTIONABLE OR POSSIBLE DELAY IN FUSION AT THIS LEVEL. THE PT HAS AN ROI-C WITH VERTEBRIDGE CONSTRUCT AT THIS LEVEL. THE CONSTRUCT WAS NOT REMOVED. THE PT IS REPORTED TO BE DOING FINE AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA ODP NA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention