BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI ARRAY SPINAL SYSTEM

    MDR report key: 983962 · Received January 15, 2008

    Report

    Report Number
    2242816-2007-00077
    Event Type
    Injury
    Date Received
    January 15, 2008
    Date of Event
    December 17, 2007
    Report Date
    December 21, 2007
    Manufacturer
    EBI
    Product Code
    MNI
    PMA / PMN Number
    K061978
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURED 5/2006; PART 594099, LOT 177846; PART 594950, LOT 207040, MANUFACTURED, 2/2007; PART 594950, LOT 248204; PART 594950, LOT 623460; PART 594950, LOT 717620, MANUFACTURED, 5/2007; PART 594950, LOT 877920, MANUFACTURED, 2/2007; PART 594950, LOT 977510, MANUFACTURED, 2/2007; PART 594950, LOT 992570, MANUFACTURED, 2/2007; PART 594950, LOT PN61A, MANUFACTURED, 8/2007; PART 594968, LOT 293841, MANUFACTURED, 12/2004; PART 94089, LOT 512470, MANUFACTURED, 5/2007; PART 94410, LOT 882982.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF BACK PAIN. A DIAGNOSIS OF HARDWARE FAILURE WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI ARRAY SPINAL SYSTEM MNI EBI PART 55005660 345164

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention