BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1996541 · Received February 18, 2011

    Report

    Report Number
    1030489-2011-00155
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8372735, 510K # K984522 WAS CLEARED IN THE UNITED STATES. 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. PER THE REPORTED EVENT, THE DEVICE MET ITS INTENDED FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGERY THREE YEARS AGO DUE TO HERNIA AT L4/5. THE REMOVAL SURGERY WAS PERFORMED BECAUSE FUSION COMPLETED. IT WAS REPORTED THAT THE PEDICLE SCREW AT LEFT S1 WAS FOUND DEFORMED AND WAS BROKEN WHILE BEING REMOVED. THE BROKEN SCREW TIP REMAINED IN THE PATIENT. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Other