BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE POLYAXIAL SPINAL SCREWS

    MDR report key: 6718061 · Received July 17, 2017

    Report

    Report Number
    2031966-2017-00084
    Event Type
    Injury
    Date Received
    July 17, 2017
    Report Date
    July 17, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NBK
    PMA / PMN Number
    K121619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION. NO RADIOGRAPHS OR FURTHER INFORMATION IS AVAILABLE TO BE ABLE TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT UNDERWENT A REVISION SURGERY FROM L3-S1 LEVELS WHERE THE PRECEPT PRODUCT WAS REMOVED. NO ALLEGATION OF PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500955 NUVASIVE POLYAXIAL SPINAL SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NBK NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other