BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAXX XD CARTRIDGE

    MDR report key: 2517554 · Received March 29, 2012

    Report

    Report Number
    MW5024854
    Event Type
    Injury
    Date Received
    March 29, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 29, 2012
    Manufacturer
    SPINEWAVE
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANT CRACKED AFTER IMPLANTING, IMPLANT WAS REMOVED AND REPLACED WITH NEW IMPLANT. SURGERY WAS EXTENDED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAXX XD CARTRIDGE CONVEX EXPANDABLE CAGE 29 X 11 X 7MM CAGE MAX SPINEWAVE 571K20.017

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability