BEUDAMED
    FDA Adverse Event Death Summary report: N

    GSB GLOBAL SPINAL BALANCE SYSTEM

    MDR report key: 6068434 · Received October 31, 2016

    Report

    Report Number
    2031966-2016-00077
    Event Type
    Death
    Date Received
    October 31, 2016
    Date of Event
    March 31, 2015
    Report Date
    February 8, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    UDI-DI
    00887517596246
    PMA / PMN Number
    K132014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS OBTAINED 01/30/2017 VIA MDR 1723170-2015-00485 INDICATING A MEDTRONIC NAVIGATION SYSTEM WAS IN USE DURING THE PATIENT'S SURGERY. THE NAVIGATION DEVICE WAS REPORTEDLY CONNECTED TO NUVASIVE INSTRUMENTS. THE SURGEON REPORTED A "1CM INACCURACY". IT IS NOT KNOWN IF THE INACCURACY WAS ENCOUNTERED AS A RESULT OF THE COMBINATION OF THE MEDTRONIC NAVIGATION SYSTEM AND NUVASIVE INSTRUMENTS. IT IS NOT KNOWN IF SAID INACCURACY RESULTED IN INJURY; HOWEVER, THE SURGERY WAS REPORTED TO HAVE CONTINUED WITHOUT DELAY AFTER USE OF THE MEDTRONIC NAVIGATION SYSTEM WAS DISCONTINUED. NO INFORMATION HAS BEEN RECEIVED INDICATING MALFUNCTION OR PERFORMANCE DETERIORATION OF A NUVASIVE DEVICE DURING SURGERY. NO OPERATIVE REPORTS HAVE BEEN RECEIVED THAT WOULD ALLOW NUVASIVE TO FURTHER EVALUATE THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    NO INFORMATION RELATED TO THE REPORT HAS BEEN RECEIVED WITH RESPECT TO USAGE OR DEVICE MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH. NO MALFUNCTIONS WERE REPORTED THAT CORRESPOND TO THE REPORTED SURGERY DATE. REVIEW OF LABELING NOTES: POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S), LOSS OF FIXATION, NONUNION OR DELAYED UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL, VASCULAR OR VISCERAL INJURY, METAL SENSITIVITY OR ALLERGIC REACTION TO A FOREIGN BODY, INFECTION, DECREASE IN BONE DENSITY DUE TO STRESS SHIELDING, PAIN, DISCOMFORT OR ABNORMAL SENSATIONS DUE TO THE PRESENCE OF THE DEVICE, NERVE DAMAGE DUE TO SURGICAL TRAUMA, BURSITIS, DURAL LEAK, PARALYSIS, DEATH.

    Description of Event or Problem · 1

    A FEMALE PATIENT (AGE UNKNOWN) UNDERWENT A SPINAL PROCEDURE INVOLVING POSTERIOR FIXATION ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT WAS REPORTED TO HAVE EXPIRED FOLLOWING A HEMOTHORAX EVENT. NO OTHER INFORMATION IS KNOWN.

    Description of Event or Problem · 1

    A FEMALE PATIENT (AGE UNKNOWN) UNDERWENT A SPINAL PROCEDURE INVOLVING POSTERIOR FIXATION ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT WAS REPORTED TO HAVE EXPIRED FOLLOWING AN HEMOTHORAX EVENT. NO OTHER INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718179 GSB GLOBAL SPINAL BALANCE SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB NUVASIVE, INC. 00887517596246

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Death