BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

    MDR report key: 3023599 · Received March 27, 2013

    Report

    Report Number
    1030489-2013-00870
    Event Type
    Death
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    UNKNOWN
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4): PER THE REPORTER, THE REPORTED EVENT WAS NOT RELATED TO THE DEVICE; WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THAT DURING A MINIMALLY INVASIVE L4-L5 TLIF AND L3-L4 DISCECTOMY THE PATIENT THEN SUFFERED AN AORTIC ANEURYSM AND DIED. THE ANEURYSM IS BEING ATTRIBUTED TO THE ANESTHESIA. PER THE HOSPITAL, THIS WAS NOT RELATED IN ANY WAY TO THE SURGERY OR THE DEVICES. NO AUTOPSY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125850 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB UNKNOWN NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death