BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL NECK SLEEVE

    MDR report key: 2830855 · Received November 13, 2012

    Report

    Report Number
    1043534-2012-01540
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 15, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01536, 01537, 01538, 01539

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT WAS SQUEAKING. POLY LINER HAD DISENGAGED FROM THE CUP. REVISED CUP, LINER, NECK, HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL NECK SLEEVE HIP COMPONENT, CODE:LZO LZO WRIGHT MEDICAL TECHNOLOGY, INC. 0201076761

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention