BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3112033 · Received May 14, 2013

    Report

    Report Number
    1030489-2013-01696
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE 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 THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT TH9-L5. IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST OP, INSTABILITY OF L5-S AND LOSS OF CORRECTION WERE CONFIRMED. IT WAS REPORTED THAT "THE L5 VERTEBRA COLLAPSED POST-OPERATIVELY, AND THAT'S WHAT CAUSED THE INSTABILITY OF THE VERTEBRAE AND LOSS OF CORRECTION." NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212097 UNK ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other