BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARRRAY SPINAL SYSTEM

    MDR report key: 596529 · Received April 19, 2005

    Report

    Report Number
    596529
    Event Type
    Injury
    Date Received
    April 19, 2005
    Date of Event
    March 1, 2005
    Report Date
    April 19, 2005
    Manufacturer
    EBI
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    S1 AND S2 SCREWS FROM EBI FAILED (BROKE). THE PATIENT RETURNED TO SURGERY FOR REMOVAL AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRRAY SPINAL SYSTEM SCREWS - ARRAY SPINAL SYSTEM 5.5 X 35 MM KWQ EBI * 310 04 26 6

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R