BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 9923484 · Received April 3, 2020

    Report

    Report Number
    3000327445-2020-00002
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Report Date
    April 22, 2020
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    LXH
    PMA / PMN Number
    K041393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS FROM CHINA AND HAD A <COPY> OF THE FASSIER-DUVAL IMPLANT IN HER BONE. TOLERANCES BETWEEN THE MALE COMPONENT AND COIL-PULLER ARE VERY PRECISE AND SIZES OF THE CHINA IMITATION ARE UNKNOWN. THE COIL PULLER BROKE AT ITS DISTAL TIP. THE SURGEON HAD TO DO AN ADDITIONAL OSTEOTOMY TO REMOVE THE BROKEN PIECE.

    Description of Event or Problem · 1

    THE COIL PULLER COMPONENT OF THE RESCUE TOOL OF THE FASSIER-DUVAL SYSTEM BROKE DURING USE. AN OPEN OSTEOTOMY WAS NECESSARY TO REMOVE THE METAL FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386136 FASSIER-DUVAL TELESCOPIC IM SYSTEM COIL PULLER SHAFT LXH PEGA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention