BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL NECK SLEEVE

    MDR report key: 2492536 · Received March 15, 2012

    Report

    Report Number
    1043534-2012-00240
    Event Type
    Injury
    Date Received
    March 15, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 14, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZO
    PMA / PMN Number
    K072656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT REVIEWED ANALYSIS SHOWED NO TREND FOR (B)(4) LOT NO: 1142313. DEVICE HISTORY RECORD REVIEWED. PACKAGE INSERT REVIEWED. PRODUCT NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED, UNDETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500 HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-00238, 00239.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO SUSPECTED REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL NECK SLEEVE HIP COMPONENT LZO WRIGHT MEDICAL TECHNOLOGY, INC. 0501142313

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R