BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL NECK SLEEVE

    MDR report key: 4221675 · Received November 3, 2014

    Report

    Report Number
    3010536692-2014-01553
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    November 22, 2013
    Report Date
    October 3, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2014-01552, -01554. THIS REPORT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAIN IN RIGHT HIP, PAIN IN ENTIRE BODY, ENDURED NUMEROUS SURGERIES; BLOOD PROBLEMS (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702384 CONSERVE(R) TOTAL NECK SLEEVE HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. 1453658

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention