BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY SPINAL SYSTEM

    MDR report key: 1408480 · Received January 19, 2009

    Report

    Report Number
    2242816-2008-00159
    Event Type
    Malfunction
    Date Received
    January 19, 2009
    Date of Event
    November 26, 2008
    Report Date
    December 18, 2008
    Manufacturer
    EBI, LLC
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT # 942254. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT DID NOT SHOW ANY NONCONFORMANCE. THE LOT WAS FOUND ACCEPTABLE TO THE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE SCREWS BROKE DURING THE SURGERY. THERE WERE EXTRA SCREWS AVAILABLE TO COMPLETE THE PROCEDURE. PT OUTCOME: THERE WAS NO ADVERSE EVENT TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM MNI EBI, LLC 434670

    Patients

    Seq Age Sex Outcome Treatment
    1