BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIIG(R) X3 MINIMALLY INVASIVE INJECTABLE GRAFT

    MDR report key: 1875283 · Received October 19, 2010

    Report

    Report Number
    1043534-2010-00433
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 14, 2010
    Report Date
    July 25, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MQV
    PMA / PMN Number
    K024336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. WMT RECALL NUMBER R10090002. INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE REPORTING PERSON ADVISED NO PATIENT INVOLVEMENT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00432. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. FUNCTIONAL TESTING OF VARIOUS LOTS. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY THE CUSTOMER STATES THAT THESE PRODUCTS HAVE A SETTING PROBLEM.

    Description of Event or Problem · 1

    ALLEGEDLY, THE CUSTOMER STATES THAT THESE PRODUCTS HAVE A SETTING PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIIG(R) X3 MINIMALLY INVASIVE INJECTABLE GRAFT BIOLOGIC COMPONENT MQV WRIGHT MEDICAL TECHNOLOGY, INC. 0401112437

    Patients

    Seq Age Sex Outcome Treatment
    1