BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAGUNA PEDICLE SCREW SYSTEM

    MDR report key: 2102890 · Received May 3, 2011

    Report

    Report Number
    3005032381-2011-00003
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 3, 2011
    Manufacturer
    PHYGEN, LLC
    Product Code
    MNI
    PMA / PMN Number
    K083826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE POST-OP VISIT, THE DOCTOR DISCOVERED THAT A LOCKING NUT IS BACKING OUT OF THE SCREW CONSTRUCT. PATIENT HAS BEEN EXPLANTED ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAGUNA PEDICLE SCREW SYSTEM SPINAL FIXATION DEVICE MNI PHYGEN, LLC LAGUNA 18378-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention