BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE FOR NAIL FIXATION

    MDR report key: 2781876 · Received October 5, 2012

    Report

    Report Number
    9615741-2012-00084
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 5, 2012
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HSB
    PMA / PMN Number
    K091788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED: DURING SURGERY USING THE PANTA DEVICE FOR NAIL FIXATION, THE SURGEON EXPERIENCED DIFFICULTY WITH COMPRESSION. THE X-RAY SHOWED THAT THE SCREWS WERE NOT IN THE NAIL. THEY WERE ANTERIOR TO THE NAIL. THE SURGEON REMOVED THE SCREWS AND PLACED THEM BY FREE HAND. THERE WAS NO PT INJURY. THE SURGERY WAS PROLONGED BY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE FOR NAIL FIXATION NA HSB NEWDEAL S.A. PANTAXI-026 TRAY

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR