BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE SPINOUS PROCESS PLATE SYSTEM

    MDR report key: 2299652 · Received October 12, 2011

    Report

    Report Number
    2031966-2011-00047
    Event Type
    Injury
    Date Received
    October 12, 2011
    Date of Event
    September 12, 2011
    Report Date
    October 11, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K073278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER INFO IS KNOWN WITH RESPECT TO PT AGE, DIAGNOSIS, BONE INTEGRITY, SPINE LEVEL AFFECTED, NEED FOR ADDITIONAL INTERVENTION, ETC. IT IS UNCLEAR THAT A PRODUCT MALFUNCTION OCCURRED. COMPONENTS USED DURING THE SURGERY ARE NOT YET KNOWN. ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN IDENTIFIED. WHEN ADDITIONAL RELEVANT INFO BECOMES KNOWN, A SUBSEQUENT REPORT WILL BE FILED. REVIEW OF LABELING NOTES: "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA..."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF A SPINOUS PROCESS PLATE, THE PT'S SPINOUS PROCESS WAS FRACTURED. AN UNSPECIFIED MALFUNCTION WAS ALLEGED. NO OTHER INFO REGARDING THE EVENT HAS BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE SPINOUS PROCESS PLATE SYSTEM SPINAL INTERLAMINAL FIXATION ORTHOSIS KWP NUVASIVE, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other