BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE COROENT SYSTEM

    MDR report key: 8465823 · Received March 29, 2019

    Report

    Report Number
    2031966-2019-00178
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Report Date
    March 2, 2019
    Manufacturer
    NUVASIVE INC.
    Product Code
    MAX
    PMA / PMN Number
    K141665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION ON PATIENTS PRE-EXISTING BONE QUALITY WAS PROVIDED. NO RADIOGRAPHS, IMAGES OR SURGICAL NOTES PROVIDED TO CONFIRM THE ALLEGED EVENT. BASED ON THE INFORMATION PROVIDED ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. NO REVISION PROCEDURE INFORMATION HAS BEEN PROVIDED. LABELING REVIEW: "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S), LOSS OF FIXATION, NONUNION OR DELAYED UNION...".

    Description of Event or Problem · 1

    ON (B)(6) 2019, THIS EVENT WAS REPORTED AT A PHYSICIAN CONFERENCE. CASE 4: PROCEDURE USING COROENT XL-H WAS PERFORMED ON AN UNKNOWN DATE. POST-OPERATIVE IMAGE REVEALED AN ILIAC SCREW BACK OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257733 NUVASIVE COROENT SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1