BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MEDTRONIC HARDWARE

    MDR report key: 3040332 · Received April 8, 2013

    Report

    Report Number
    1030489-2013-00947
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 9, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS CONSIDERED TO HAVE A "FAILED LOW BACK SURGERY." FROM AN UNKNOWN SPINAL SURGERY. THE PATIENT IS IN CONSTANT, OFTEN SEVERE PAIN. THE PATIENT HAD AN UNKNOWN CAGE IMPLANTED FOR FUSION YEARS AGO. THE PATIENT WAS DOING FINE INITIALLY AFTER SURGERY, THE PATIENT HAS BEEN IN PAIN EVER SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142800 UNKNOWN MEDTRONIC HARDWARE NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1