BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERILOC ANKLE FUSION TTC PLATE SCREW

    MDR report key: 2882286 · Received December 20, 2012

    Report

    Report Number
    1020279-2012-00695
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    January 1, 1901
    Report Date
    November 30, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED DUE BACK-OUT ISSUES WITH THE SCREW AND PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERILOC ANKLE FUSION TTC PLATE SCREW SCREW HRS SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R