BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARLOTTE(TM) EXTENDED MTP FUSION PLATE

    MDR report key: 1811536 · Received August 23, 2010

    Report

    Report Number
    1043534-2010-00341
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    July 10, 2010
    Report Date
    July 8, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    PMA / PMN Number
    K042205
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXPLANTED DATE - (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500 HAS NOT BEEN RECIEVED FROM THE USER FACILITY. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO A BROKEN COMPONENT.

    Description of Event or Problem · 1

    (B)(4). EXPLANTED DATE - (B)(6) 2010.

    Description of Event or Problem · 1

    CORRECTED DATA RECEIVED (B)(6) 2010: EXPLANTED DATE - (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARLOTTE(TM) EXTENDED MTP FUSION PLATE SMALL JOINT COMPONENT HRS WRIGHT MEDICAL TECHNOLOGY, INC. 025124089

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R