BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI-CP IMPLANT SET

    MDR report key: 4184219 · Received October 16, 2014

    Report

    Report Number
    9615741-2014-00053
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HRS
    PMA / PMN Number
    K093914
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED "4 HOLE UNI-CP PLATE BROKE IN THE CC (CALCANEAL CUBOID) JOINT". ADD'L INFO WAS RECEIVED ON OCTOBER 2014 FROM THE COMPANY REP. THE BREAKAGE WAS REPORTED TO HAVE OCCURRED ON AN UNK DATE (AFTER THE INITIAL IMPLANTATION). THE INITIAL IMPLANTATION SURGERY DATE WAS REPORTED TO BE A FEW YEARS AGO. THE DEVICE WAS EXPLANTED SURGICALLY ON (B)(6) 2014. THE SURGEON REMOVED THE PLATE. THERE WAS NO OTHER INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656907 UNI-CP IMPLANT SET NA HRS NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention