BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE PRECEPT SPINAL SYSTEM

    MDR report key: 6638670 · Received June 13, 2017

    Report

    Report Number
    2031966-2017-00070
    Event Type
    Death
    Date Received
    June 13, 2017
    Date of Event
    May 17, 2017
    Report Date
    June 13, 2017
    Manufacturer
    NUVASIVE, INC
    Product Code
    NKB
    PMA / PMN Number
    K122352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATION OF PRODUCT MALFUNCTION REPORTED. ALTHOUGH ROOT CAUSE CANNOT BE DETERMINED, INFORMATION SUGGEST THAT PATIENT'S PRE-EXISTING CONDITION MAY BE A CONTRIBUTING CAUSE. NO RADIOGRAPHS NOR PRODUCT HAVE BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A (B)(6) Y/O FEMALE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT THE T12-S1 LEVELS. IT WAS REPORTED THE SURGERY WENT WELL; HOWEVER, THE PATIENT'S CONDITION WORSENED AFTER SURGERY AND LATER EXPIRED. NO ALLEGATION OF PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417098 NUVASIVE PRECEPT SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB NUVASIVE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death