BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASIER DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 10236693 · Received July 6, 2020

    Report

    Report Number
    3000327445-2020-00004
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 11, 2020
    Report Date
    July 6, 2020
    Manufacturer
    PEGA MEDICAL INC
    Product Code
    LXH
    UDI-DI
    07540194007193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON INFORMED THAT DURING SURGERY IN A PATIENT WITH CONGENITAL PSEUDARTHROSIS, FOR REPLACING AN EXISTING FASSIER DUVAL NAIL BY A LARGER ONE, THE FEMALE RETRIEVER (FRT100) USED FOR THE REMOVAL PRESENTED A MISALIGNMENT OF THE TWO HALVES, CAUSING THAT THE INSTRUMENT DID NOT FIT WITH THE HEX HOLE OF THE IMPLANT TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701506 FASIER DUVAL TELESCOPIC IM SYSTEM FEMALE RETRIEVER Ø3.2MM LXH PEGA MEDICAL INC FRT100 160512-01 07540194007193

    Patients

    Seq Age Sex Outcome Treatment
    1