BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE LONG LATERAL SPINAL SYSTEM

    MDR report key: 4929253 · Received July 15, 2015

    Report

    Report Number
    2031966-2015-00040
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 14, 2015
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K122081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AND MAY HAVE BEEN DISCARDED AT THE USER FACILITY. ROOT CAUSE OF THE EVENT HAS NOT BEEN IDENTIFIED; HOWEVER, THE REPORTED EVENT IS CONSISTENT WITH PATIENT-RELATED FACTORS AS A CONTRIBUTOR. LABELING REVIEW: "CONTRAINDICATIONS INCLUDE BUT ARE NOT LIMITED TO: PATIENTS WITH INADEQUATE BONE STOCK OR QUALITY." "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: FRACTURE OF THE VERTEBRA".

    Description of Event or Problem · 1

    DURING PLACEMENT OF ANTEROLATERAL FIXATION CONSTRUCT, THE SURGEON ENCOUNTERED DIFFICULTY IN DISENGAGING INSTRUMENTS. AS A RESULT, THE SURGEON DECIDED TO IMPLANT POSTERIOR FIXATION. DURING THE REMOVAL PROCESS, THE ANTEROLATERAL BOLT WAS PUSHED PAST THE MARGIN OF THE VERTEBRAL BODY, NECESSITATING REMOVAL THROUGH A SECONDARY CONTRALATERAL INCISION. IT IS UNCLEAR IF THE PATIENT HAS PERMANENT DAMAGE TO THE VERTEBRAL BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460802 NUVASIVE LONG LATERAL SPINAL SYSTEM NUVASIVE LONG LATERAL SPINAL SYSTEM KWQ NUVASIVE, INC. 1726545

    Patients

    Seq Age Sex Outcome Treatment
    1 Other