BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERTAN

    MDR report key: 2111172 · Received June 2, 2011

    Report

    Report Number
    1020279-2011-00185
    Event Type
    Injury
    Date Received
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    SMITH & NEPHEW, INC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW MIGRATED 6-12 MONTHS AFTER IMPLANTATION REQUIRING A REVISION SURGERY TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERTAN SCREW HWC SMITH & NEPHEW, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention