BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINEART MIS K-WIRE 1.2 MM LENGTH 450 MM

    MDR report key: 3260008 · Received July 26, 2013

    Report

    Report Number
    MW5031241
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 19, 2013
    Report Date
    July 26, 2013
    Manufacturer
    SPINEART SA
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN BROUGHT TO SPINEART ATTENTION THAT DURING A MINIMAL INVASIVE SURGERY, THREE K-WIRES -MIS-IN 02 00-N- INSTRUMENTS BROKE. DIAGNOSIS OR REASON FOR USE: PEDICLE SCREW GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349807 SPINEART MIS K-WIRE 1.2 MM LENGTH 450 MM K-WIRE HTY SPINEART SA 1-5511
    349808 SPINEART MIS K-WIRE 1.2 MM LENGTH 450 MM K-WIRE HTY SPINEART SA 1-5511
    350125 SPINEART MIS K-WIRE 1.2 MM LENGTH 450 MM K-WIRE HTY SPINEART SA 1-5511

    Patients

    Seq Age Sex Outcome Treatment
    1