BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUNTER TENDON ROD

    MDR report key: 3170391 · Received June 14, 2013

    Report

    Report Number
    1043534-2013-01044
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 24, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. PHOTOGRAPHIC IMAGES WERE MADE OF RETURNED PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS 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. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY POST-OP CONSULTATION ON (B)(4) 2013 - NO OPEN SPOTS. BUT ON (B)(4) 2013, PT. DEVELOPED OPEN WOUND SPOTS ON PROXIMAL AND DISTAL PORTIONS OF FINGER. ON (B)(6) 2013 PT HAD DEVELOPED LOW GRADE SEPSIS. DR REMOVED ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271148 HUNTER TENDON ROD SMALL JOINT COMPONENT, CODE:HXA HXA WRIGHT MEDICAL TECHNOLOGY, INC. 1458122

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention