BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARLOTTE(R) CLAW(R) PLATE

    MDR report key: 3050994 · Received April 10, 2013

    Report

    Report Number
    1043534-2013-00624
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    November 1, 2012
    Report Date
    February 27, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED.(B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY A 4-HOLE PLATE BROKE AT THE JUNCTION WHERE THE TWO MIDDLE CROSS BARS MEET THE TWO SCREW HOLES ON THE SIDE OF THE PLATE. PLATE WAS USED FOR A TN FUSION. PATIENT DID NOT REPORT TRAUMA TO THE SITE THAT MAY HAVE CAUSED BREAKAGE. REVISED (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153163 CHARLOTTE(R) CLAW(R) PLATE SMALL JOINT COMPONENT, CODE:HRS HRS WRIGHT MEDICAL TECHNOLOGY, INC. 0111256604

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention