BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZAVATION POLYAXIAL SCREW

    MDR report key: 9107069 · Received September 23, 2019

    Report

    Report Number
    3008583793-2019-00002
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    July 2, 2018
    Report Date
    September 6, 2019
    Manufacturer
    ZAVATION MEDICAL PRODUCTS
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018, DR. (B)(6) DID A PLIF USING THE ZAVATION INTERBODY CAGE AND PEDICLE SCREWS. DR. (B)(6) STATED THAT ON A POST-OP IMAGE, HE IS ABLE TO SEE METAL IN THE PATIENT'S SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901897 ZAVATION POLYAXIAL SCREW PEDICALE SCREW MNI ZAVATION MEDICAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1