BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI ARRAY SPINAL SYSTEM

    MDR report key: 1123584 · Received August 20, 2008

    Report

    Report Number
    2242816-2008-00119
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 29, 2008
    Manufacturer
    EBI, L.P.
    Product Code
    NKB
    PMA / PMN Number
    K061563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED FOR THE INVOLVED DEVICES AND NO DISCREPANCIES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SACRUM SCREWS HAVE BROKEN POST TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-5 AND L5-S1. THE SCREWS REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI ARRAY SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB EBI, L.P. 735430

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR