BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTA INSTRUMENT SET

    MDR report key: 3964289 · Received June 19, 2014

    Report

    Report Number
    9615741-2014-00030
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 4, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    LXH
    PMA / PMN Number
    K091788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PANTA SET WAS SENT BY THE COMPANY REP AND A 'CURSORY INSPECTION OF THE ALIGNMENT JIG WAS PERFORMED AND IT WAS DETERMINED THAT THE NAIL FIXATION DEVICE HAD A DAMAGED INTERNAL THREAD.' ADD'L INFO WAS RECEIVED FROM THE COMP REP "THE SURGEON INDICATED THE HOLES DID NOT LINE UP DIRECTLY WITH THE NAIL IT SEEMED. EVERYTHING ELSE SEEMED TO WORK CORRECTLY." THERE WAS NO INJURY OR ADVERSE CONSEQUENCE TO THE PT AND NO REPORTED DELAY IN SURGERY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360970 PANTA INSTRUMENT SET NA LXH NEWDEAL SAS PANTAXL-053

    Patients

    Seq Age Sex Outcome Treatment
    1