BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02279

    MDR report key: 3091583 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02279
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THE SURGEON PLANNED A HARDWARE REMOVAL OF AN ANKLE ARTHODESIS PLATE BECAUSE A COUPLE OF SCREWS HAD LOOSENED AND BACKED OUT. THE SURGEON SUCCESSFULLY REMOVED THE PLATE AND SIX SCREWS, INCLUDING THE SCREW THAT WAS PLACED OUTSIDE THE ANKLE INDEPENDENTLY. THE SURGEON ALSO REMOVED THE BROKEN FIBULA PLATE AND SIX SCREWS AS WELL. THE SURGEON DID NOT REPLACE THE PATIENT WITH ANYTHING ADDITIONAL AFTER REMOVING ALL HARDWARE, TWO PLATES AND TWELVE SCREWS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194671 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention