BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLS

    MDR report key: 7018410 · Received November 10, 2017

    Report

    Report Number
    3003898228-2017-00012
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    August 2, 2017
    Report Date
    November 10, 2017
    Manufacturer
    FH INDUSTRIE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PLUSIEURS INCOMPATIBILITÉS ENTRE DES POIGNÉES UNIVERSELLES (RÉF(B)(4)) DU VISEUR TLS ET DES CROCHETS POINTE À POINTE TIBIAUX (RÉF (B)(4)) OU FÉMORAUX (RÉF (B)(4)) ONT ÉTÉ SIGNALÉES : LORS DE LA VISÉE, IL EXISTE UN DÉCALAGE ENTRE LA POINTE DE LA BROCHE ET LA POINTE DU CROCHET. SEVERAL INCOMPATIBILITIES BETWEEN THE TLS UNIVERSAL GUIDE HANDLE (REF (B)(4)) AND THE TIBIAL (REF (B)(4)) OR FEMORAL (REF (B)(4)) GUIDE POINT TO POINT HAVE BEEN NOTICED: THERE IS AN OFFSET BETWEEN THE TIP OF THE PIN AND THE TIP OF THE TIBIAL OR FEMORAL GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799795 COLS UNIVERSAL GUIDE LXH FH INDUSTRIE

    Patients

    Seq Age Sex Outcome Treatment
    1