BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY SPINAL SYSTEM

    MDR report key: 1014030 · Received March 14, 2008

    Report

    Report Number
    2242816-2008-00030
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 9, 2008
    Report Date
    February 25, 2008
    Manufacturer
    EBI
    Product Code
    KWP
    PMA / PMN Number
    K010515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TORQUE WRENCH STRIPPED WHILE TIGHTENING A LOCK NUT, AND COULD NOT TIGHTEN ALL THE WAY. PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY SPINAL SYSTEM KWP EBI 31578

    Patients

    Seq Age Sex Outcome Treatment
    1