BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIGEN INSTRUMENTS

    MDR report key: 2901441 · Received January 8, 2013

    Report

    Report Number
    1020279-2013-00017
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE ENGAGING\DISENGAGING THE DEVICE INTRA-OPERATIVELY, THERE WAS A DELAY OF SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8577 TRIGEN INSTRUMENTS NAIL PROX DROP LXH SMITH & NEPHEW, INC. 09GCL0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R