BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI-CP / PLAQUE A

    MDR report key: 3835914 · Received May 13, 2014

    Report

    Report Number
    9615741-2014-00021
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HRS
    PMA / PMN Number
    K091609
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED A 'UNI-CP 4 HOLE PLATE BROKE ON THE TN JOINT AND HAD TO BE REMOVED'. ON (B)(4) 2014, ADD'L INFO WAS REQUESTED AND REC'D FROM THE REPRESENTATIVE WHO WAS PRESENT AT THE DEVICE REMOVAL SURGERY. THE PRECISE INITIAL IMPLANT SURGERY DATE WAS 'NOT KNOWN'. ALTHOUGH IT WAS INITIALLY REPORTED THAT THE DEVICE BROKE ON THE 'TN' JOINT. F/U INFO CONFIRMED THAT THE DEVICE WAS A UNI-CP 4 HOLE PLATE THAT WAS IMPLANTED ON THE LEFT CALCANEAL-CUBOID JOINT (CC JOINT). ON AN UNKNOWN DATE FOLLOWING THE IMPLANT SURGERY THE PATIENT EXPERIENCED PAIN IN HIS LEFT FOOT. ON AN UNKNOWN DATE FOLLOWING THE IMPLANT SURGERY AND THE EVENT OF PAIN, AN X-RAY WAS TAKEN WHICH REVEALED THE DEVICE BROKE WHILE IMPLANTED IN THE PATIENT. ON (B)(6) 2014, THE BROKEN PLATE WAS REMOVED AND THE CC JOINT APPEARED TO HAVE FUSED. ADD'L INFO WAS REQUESTED FROM THE SURGEON BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285201 UNI-CP / PLAQUE A NA HRS NEWDEAL SAS EMTV.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention