BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE VUEPOINT OCT SYSTEM

    MDR report key: 4943526 · Received July 16, 2015

    Report

    Report Number
    2031966-2015-00042
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    July 14, 2014
    Report Date
    July 16, 2015
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K090176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. 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..." "...LOSS OF FIXATION..."

    Description of Event or Problem · 1

    FOLLOWING IMPLANTATION OF POSTERIOR PEDICLE SCREW FIXATION DEVICE EXTENDING FROM THE CRANIUM TO T1 SPINE LEVEL ON (B)(6) 2013, THE PATIENT REPORTED THAT AFTER DRIVING THROUGH A LARGE POTHOLE THAT HE "FELT A POP". FOLLOW-UP FILMS NOTED PRESENCE OF A SCREW HAVING PULLED OUT OF BONE AT T1 AND A T2 COMPRESSION FRACTURE. IT IS NOT KNOWN IF REVISION SURGERY WAS SUBSEQUENTLY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463509 NUVASIVE VUEPOINT OCT SYSTEM NUVASIVE VUEPOINT OCT SYSTEM KWP NUVASIVE, INC. 7905424

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other