BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BICON-PLUS

    MDR report key: 2931602 · Received January 28, 2013

    Report

    Report Number
    9613369-2013-00006
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    SMITH&NEPHEW - SWITZERLAND
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY TIME WAS DELAYED 1H AND 20 MINUTES DUE TO COMPLICATIONS WHILE USING THE DEVICE. THE SURGERY WAS COMPLETED WITHOUT ANY FURTHER INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36643 BICON-PLUS BICON-PLUS TURNING INSTR.W.COLLET LEVER LXH SMITH&NEPHEW - SWITZERLAND D4

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O (B)(4) -BICON-PLUS DRAW ROD - D9| (B)(4) - BICON-PLUS TI SHELL - D1211768| (B)(4) -BICON-PLUS COLLET 3 -F10