BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI SYNERGY SPINE SYSTEM

    MDR report key: 806274 · Received January 3, 2007

    Report

    Report Number
    2242816-2006-00043
    Event Type
    Malfunction
    Date Received
    January 3, 2007
    Manufacturer
    EBI, L.P.
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D4: ASSOCIATED CATALOG AND LOT NUMBERS ARE AS FOLLOWS: QTY 1, CAT. NO. 6016, NO. 40279 QTY 12, CAT. NO. 6101, LOT NO. 38041 (X9), 40079 (X3) QTY 12, CAT. NO. 6102, LOT NO. 40458 (X10), 40279 (X2) QTY 12, CAT. NO. 6113M, LOT NO. 40461 (X5), 40841 (X7).

    Description of Event or Problem · 1

    THE CAP NUT OF THE SYNERGY SPINE SYSTEM CAME OUT OF THE SCREW. PATIENT OUTCOME: NON-UNION, PATIENT BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI SYNERGY SPINE SYSTEM MNH MNH EBI, L.P. * 40458, 40279

    Patients

    Seq Age Sex Outcome Treatment
    1 *