BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY SPINAL SYSTEM IMPLANTS AND INSTRUMENTS

    MDR report key: 2408316 · Received January 10, 2012

    Report

    Report Number
    0002242816-2012-00004
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 12, 2011
    Manufacturer
    EBI, LLC
    Product Code
    KWP
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WA REPORTED THAT THE SET SCREW STRIPPED DURING INSERTION.PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM IMPLANTS AND INSTRUMENTS MEDIUM CROSS CONNECTOR KWP EBI, LLC N/A 2215001

    Patients

    Seq Age Sex Outcome Treatment
    1