BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MEDTRONIC HARDWARE

    MDR report key: 2874144 · Received December 14, 2012

    Report

    Report Number
    1030489-2012-02826
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES HAVE BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR DECOMPRESSION AND INTERBODY FUSION. IT IS ALLEGED THAT THE PATIENT WAS CAUSED SEVERE INJURIES, GREAT PAIN AND SUFFERING AND WILL HAVE TO UNDERGO FUTURE MEDICAL TREATMENT. IT IS FURTHER ALLEGED THAT THE PATIENT IS DISABLED FROM NORMAL ACTIVITIES AND EMPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MEDTRONIC HARDWARE KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other