BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL NECK SLEEVE

    MDR report key: 3932799 · Received July 14, 2014

    Report

    Report Number
    3010536692-2014-00986
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    March 27, 2013
    Report Date
    April 10, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT REVIEW WAS CONDUCTED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. THE TRENDS WILL BE EVALUATED. THE REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 3010536692-2014-00674,00675, 00985, 00987, AND 00988.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS (LEFT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409620 CONSERVE(R) TOTAL NECK SLEEVE HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. 06856067610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention