BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALOR(R) TARGETING GUIDE

    MDR report key: 2507917 · Received March 28, 2012

    Report

    Report Number
    1043534-2012-00237
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 23, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSB
    PMA / PMN Number
    K090857
    Removal / Correction Number
    R12020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. THE COMPLAINT WAS REVIEWED AND X-RAYS WERE PROVIDED. (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY THE INSTRUMENT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALOR(R) TARGETING GUIDE SMALL JOINT INSTRUMENT HSB WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1