BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE PS SET SCREW

    MDR report key: 3161581 · Received May 7, 2013

    Report

    Report Number
    3004638600-2013-00006
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K081228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOOSE SET SCREWS WERE NOTED DURING A ROUTINE POST-OPERATIVE X-RAY EXAMINATION FOLLOWING A PEDICLE SCREW CONSTRUCT EXTENSION USING ILIAC SCREWS. THE PATIENT UNDERWENT SURGERY TO REMOVE AND REPLACE THE SET SCREWS. THE SURGERY WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200042 CAPSURE PS SET SCREW PEDICLE SCREW SYSTEM MNI SPINE WAVE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention