BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAGUNA PEDICLE SCREW SYSTEM

    MDR report key: 2860169 · Received November 21, 2012

    Report

    Report Number
    3005032381-2012-00003
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 21, 2012
    Manufacturer
    PHYGEN, LLC
    Product Code
    MNI
    PMA / PMN Number
    K083826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE TIP OF SCREW BROKE OFF ON THE RIGHT SIDE OF L-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAGUNA PEDICLE SCREW SYSTEM SPINAL FIXATION DEVICE MNI PHYGEN, LLC LAGUNA 16970-1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR