BEUDAMED
    FDA Adverse Event Summary report: N

    SPINE CAGES

    MDR report key: 7366038 · Received March 22, 2018

    Report

    Report Number
    MW5076049
    Date Received
    March 22, 2018
    Date of Event
    March 14, 2018
    Report Date
    March 20, 2018
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    MQP
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON HAD ISSUES FITTING THE SPINE CAGE AND USED MANIPULATION METHODS TO FIT IT. HE THEN DECIDED TO USE ANOTHER SIZED CAGE AND USED THE CAGE HE HAD TRIED TO FIT IN ANOTHER AREA. ON INSPECTION OF THE SPINAL CAGE, IT WAS NOTED TO HAVE CRACKS IN IT. THE SURGEON FELT THESE CRACKS WOULD NOT COMPROMISE THE CAGE ITSELF AND IMPLANTED IT IN THE PATIENT. DATES OF USE: (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: LUMBAR/SPINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204184 SPINE CAGES SPINAL DEVICES MQP SPINAL ELEMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR