BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INERTIA PEDICLE SCREW SYSTEM

    MDR report key: 8002061 · Received October 24, 2018

    Report

    Report Number
    3007922509-2018-00004
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    September 19, 2017
    Report Date
    June 27, 2018
    Manufacturer
    NEXXT SPINE LLC
    Product Code
    MNI
    UDI-DI
    00889929010181
    PMA / PMN Number
    K090984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADVISED SURGEON NOT TO USE FUSION BASED HARDWARE WITH NON-FUSION BASED HARDWARE.

    Description of Event or Problem · 1

    FUSION DID NOT OCCUR AS INTENDED, RESULTING IN CONSTRUCT FAILURE AND ULTIMATELY SCREW FRACTURE. CONSTRUCT WAS IMPLANTED OFF-LABEL IN THAT THE PEDICLE SCREW FUSION HARDWARE WAS PAIRED WITH A NON-FUSION COFLEX IMPLANT OF ANOTHER MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840593 INERTIA PEDICLE SCREW SYSTEM INERTIA PEDICLE SCREW SYSTEM MNI NEXXT SPINE LLC 10-60-4530 NS5996A 00889929010181

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R