BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARLOTTE(R) CLAW(R) SCREW

    MDR report key: 2191807 · Received August 4, 2011

    Report

    Report Number
    1043534-2011-00393
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    April 20, 2011
    Report Date
    July 28, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    PMA / PMN Number
    K080295
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DID NOT CONTRIBUTE TO EVENT. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE PRODUCT WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICE #2: INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO ADDTIONAL INFORMATION OR DEVICE HAS BEEN RECEIVED FROM THE SURGEON. WITHOUT PATIENT IDENTIFIER, THE COMMUNICATION WITH THE USER FACILITY IS LIMITED. TO DATE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00392.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARLOTTE(R) CLAW(R) SCREW SMALL JOINT COMPONENT HRS WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention