BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE FOR NAIL FIXATION

    MDR report key: 2852400 · Received November 13, 2012

    Report

    Report Number
    9615741-2012-00091
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 13, 2012
    Manufacturer
    NEWDEAL S.A.S
    Product Code
    HSB
    PMA / PMN Number
    K091788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PANTA COMPRESSION DEVICE. PRODUCT NUMBER 519130 WAS USED DURING THIS SURGERY. TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE SURGEON HAD ¿AN ISSUE WHEN HE INSERTED THE TIBIAL COMPRESSION RODS. THE ROD WAS NOT IN THE HOLE AS EXPECTED.¿ THERE WAS NO PATIENT INJURY. THERE WAS AN INCREASE OF SURGERY TIME OF 30 MINUTES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1