BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED POLYAXIAL SCREW 6.5MM X 35MM

    MDR report key: 3879703 · Received April 7, 2014

    Report

    Report Number
    2184052-2014-00060
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    February 3, 2014
    Report Date
    March 10, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K100845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREW HAD TO BE REPOSITIONED POST-OPERATIVELY AS THE PT WAS EXPERIENCING RADICULAR SYMPTOMS. DURING THE ORIGINAL SURGERY L5 THRU S1 WAS TREATED. AT POST-OP FOLLOW UP THE PT REPORTED EXPERIENCING RADICULAR SYMPTOMS AND THIS LEAD THE SURGEON TO BELIEVE THE RIGHT L5 SCREW WAS MISPLACED. THE SCREWS AT L5 WERE REMOVED AND REPLACED WITH 6.5MMX40MM SCREWS AND NEW LOCKING CAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207059 CANNULATED POLYAXIAL SCREW 6.5MM X 35MM CANNULATED POLYAXIAL SCREW 6.5MM X 35MM NKB ZIMMER SPINE, INC. 3505-6535 TBC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention