BEUDAMED
    FDA Adverse Event Other Summary report: N

    VUEPOINT OCT SYSTEM

    MDR report key: 3855551 · Received May 21, 2014

    Report

    Report Number
    2031966-2014-00032
    Event Type
    Other
    Date Received
    May 21, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 21, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K093319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) . CT SCAN OF THE EVENT WERE RECEIVED, BUT WERE INCONCLUSIVE. PT UNDERWENT REVISION SURGERY TO REPLACE LATERAL MASS SCREWS AND EXTEND CONSTRUCT TO C4. PT IS REPORTEDLY DOING WELL POST REVISION SURGERY. NO SCREWS HAVE BEEN RETURNED. THEY WERE DISCARDED BY THE HOSP AND NO FURTHER EVAL OF THE PRODUCT CAN BE COMPLETED AT THIS TIME. THE ROOT CAUSE OF THIS REPORTED EVENT HAS NOT BEEN DETERMINED, NO CONCLUSION CAN BE DRAWN, BUT THE PT'S RADIATION TREATMENT FOR METASTATIC LIVER CANCER MAY HAVE CAUSED OR CONTRIBUTED TO THE POOR BONE QUALITY.

    Description of Event or Problem · 1

    INITIAL POSTERIOR CERVICAL FIXATION SURGERY WAS ON (B)(6) 2013 IN WHICH 6 LATERAL MASS SCREWS AND 4 PEDICLE SCREWS WERE PLACED BILATERALLY C5 TO T4. ON (B)(6) 2014, IT WAS REPORTED THAT 4 LATERAL MASS SCREWS DISASSOCIATED FROM THE BONE. PT'S ACTIVITY LEVEL IS UNK. PT COMPLIANCE WITH POST SURGICAL INSTRUCTIONS IS UNK. PT NOTED TO HAVE FALLEN PRIOR TO EVENT DISCOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303929 VUEPOINT OCT SYSTEM SPINAL INTERLAMINAL FIXATION ORTHOSIS KWP NUVASIVE, INC. 8975312 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention