BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 10040546 · Received May 8, 2020

    Report

    Report Number
    3000327445-2020-00003
    Event Type
    Injury
    Date Received
    May 8, 2020
    Date of Event
    April 14, 2020
    Report Date
    May 7, 2020
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    LXH
    PMA / PMN Number
    K041393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE MALE DRIVER BROKE IN THE PATIENT'S CANAL. THEY WERE ABLE TO REMOVE THE MAIN BROKEN PARTS THRU THE OSTEOTOMY. HOWEVER, SMALL FRAGMENTS OF THE INSTRUMENT REMAINED IN THE CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501099 FASSIER-DUVAL TELESCOPIC IM SYSTEM MALE DRIVER 3.2MM LXH PEGA MEDICAL INC. 100702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other