BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE TIBIA GI

    MDR report key: 2022627 · Received March 17, 2011

    Report

    Report Number
    1020279-2011-00084
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 17, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    EKD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT FIT CORRECTLY AND EXTENDED SURGERY TIME BY 30-60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONAIRE TIBIA GI VISIONAIRE PROX TIB CUTTING BLOCK - LGNP EKD SMITH & NEPHEW, INC. PM020931V1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization