BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL NECK SLEEVE

    MDR report key: 2963571 · Received February 15, 2013

    Report

    Report Number
    1043534-2013-00300
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 14, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO FAILURE WAS DETECTED AND PRODUCT WITHIN SPECIFICATION. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00297, 00298, 00299.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68804 CONSERVE(R) TOTAL NECK SLEEVE HIP COMPONENT, CODE:LZO LZO WRIGHT MEDICAL TECHNOLOGY, INC. 0111297754

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention