BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROI-C

    MDR report key: 3272606 · Received August 5, 2013

    Report

    Report Number
    MW5031316
    Event Type
    Injury
    Date Received
    August 5, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 22, 2013
    Manufacturer
    LAR
    Product Code
    ODP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACDFS C4-5 ON (B)(6) 2013 AND EXPLANT OF ROI-C FOR NON-UNION. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: CERVICAL SPONDYLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364921 ROI-C ROI-C O PROFILE ODP LAR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization