BEUDAMED
    FDA Adverse Event Summary report: N

    COLORADO SPINAL SYSTEM

    MDR report key: 2011153 · Received March 8, 2011

    Report

    Report Number
    1030489-2011-00254
    Date Received
    March 8, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF DEVICE HISTORY RECORDS IS NOT POSSIBLE AT THIS TIME WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION INSTRUMENTATION AT T12/L3 ONE AND A HALF YEARS AGO. A REMOVAL SURGERY WAS PERFORMED DUE TO BONE UNION. THE SCREW AT T11 ON THE RIGHT SIDE BROKE DURING REMOVAL. THE TIP OF THE BROKEN SCREW COULD NOT BE REMOVED AND REMAINED IN THE VERTEBRAL BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLORADO SPINAL SYSTEM KWP MEDTRONIC SOFAMOR DANEK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SET SCREWS, ROD, HOOKS