BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3120740 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01726
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KXE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN ULNA IMPLANT. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS THE REPORTED DEVICE WAS NOT PROVIDED FOR EVALUATION. AN X-RAY WAS PROVIDED TO A CONSULTING CLINICIAN WHO REJECTED IT FOR REVIEW AS INSUFFICIENT INFORMATION WAS PROVIDED; HOWEVER, THE X-RAY DID CONFIRM THE FRACTURED ULNA. DEVICE HISTORY REVIEW: COULD NOT BE PERFORMED AS NO PRODUCT IDENTIFICATION WAS PROVIDED. COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS NO PRODUCT IDENTIFICATION WAS PROVIDED. THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS A BROKEN ULNA IMPLANT ACCORDING TO THE REPORT THE SURGEON RECEIVED. THIS PATIENT HAS HAD CHRONIC ISSUES WITH THESE IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS A BROKEN ULNA IMPLANT ACCORDING TO THE REPORT THE SURGEON RECEIVED. THIS PATIENT HAS HAD CHRONIC ISSUES WITH THESE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222516 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KXE STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention