BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4251352 · Received November 3, 2014

    Report

    Report Number
    4251352
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 17, 2014
    Report Date
    November 3, 2014
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EARLIER THIS YEAR, A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF THE RIGHT ANKLE SUBSEQUENT TO A FALL. POST OPERATIVELY PATIENT DID WELL UNTIL HE WAS INVOLVED IN AN AUTOMOBILE ACCIDENT AND HE STARTED TO HAVE CHRONIC PAIN. IMPLANTED HARDWARE WAS REMOVED INCLUDING THE THREE (3) IMPLANTED SCREWS, ONE OF WHICH HAD BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702221 * SCREW, FIXATION, BONE HWC SYNTHES (USA) PRODUCTS LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR THERE WAS AN INTERMEDULLARY THAT WAS IMPLANTED| WITH THE ORIGINAL SURGERY.