BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAGUNA PEDICLE SCREW SYSTEM

    MDR report key: 3181832 · Received June 14, 2013

    Report

    Report Number
    3005032381-2013-00001
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 13, 2013
    Manufacturer
    PHYGEN, LLC
    Product Code
    MNH
    PMA / PMN Number
    K083826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING FOLLOW-UP OF PATIENT, WHO WAS OPERATED ON (B)(6) 2010, WITH A L4-S1 INTERBODY AND POSTERIOR FUSION, X-RAYS SHOWED A DISENGAGED LOCKING NUT. X-RAYS SHOW NO INFECTION OR LOOSENING. EFFUSION SEEMS SOLID. THERE IS NO EVIDENCE OF MOTION OF THE HARDWARE OR FUSION. PATIENT MAY HAVE STENOSIS ABOVE THE OLD FUSION. AN MRI WILL BE TAKEN AND THE PATIENT WILL BE MONITORED CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271682 LAGUNA PEDICLE SCREW SYSTEM SPINAL FIXATION DEVICE MNH PHYGEN, LLC LAGUNA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1